FDA FY 2026 Biosimilar Plan: Key Insights for Manufacturers and Investors

The FDA’s FY 2026 Legislative Proposal reaffirms its strong support for biosimilars as a key means to reduce drug costs and enhance competition. Building on its Biosimilars Action Plan, the Agency emphasizes streamlined approval pathways, enhanced interchangeability guidance, and policies aimed at overcoming scientific and manufacturing complexity. The FDA also signals that future resources will focus on advancing analytical tools and regulatory science to boost biosimilar adoption while safeguarding quality, safety, and efficacy.

Notably, the FDA underscores the importance of transparency and predictability—pillars of the Agency’s renewed commitment. This means clearer timelines, more robust FDA‑industry dialogue, and continued investment in research infrastructure to facilitate complex biologic comparisons. The proposal signals readiness to refine naming conventions, labeling standards, and post‑market surveillance to help manufacturers navigate biosimilar development while also ensuring clinician and patient confidence.

In short, the FDA is actively shaping an ecosystem that supports biosimilar innovation—with an eye on reducing health care spending and expanding patient access—while maintaining rigorous safety standards.

Navigating the evolving FDA landscape requires expert guidance. At Lanton Law, we help biosimilar manufacturers and partners strategize around regulatory hurdles, streamline business planning, and align submissions with FDA expectations. If you’re currently preparing for 2026 changes—especially concerning interchangeability, analytics, naming or the like—reach out to Lanton Law today for proactive, tailored counseling to position your biosimilar programs for success.

Rising API Tariffs Are Forcing Pharma to Shift R&D Resources

In Part 3 of our interview; Lanton Law speaks with Applied Clinical Trials on the highlights of how tariffs on active pharmaceutical ingredients could affect resources for maintaining and accelerating R&D pipelines. The interview can be heard here.

Lanton Law Talks to Applied Clinical Trials About How FDA Cuts Are Creating New Bottlenecks in Clinical Operations

In Part 2 of the interview; Ron Lanton, partner, Lanton Law, talks FDA layoffs and their impact on inspections and clinical trial timelines. The interview can be seen here.

New Federal Directives to Enhance U.S. Drug Manufacturing: Compliance Insights for Healthcare

On May 5, 2025, President Donald Trump signed the Executive Order on Regulatory Relief to Promote Domestic Production of Critical Medicines, marking a significant move to reduce America's reliance on foreign pharmaceutical manufacturing. This initiative aims to streamline regulatory processes, making it more feasible for domestic facilities to produce essential medicines.

Key directives include:

• FDA Regulatory Streamlining: The Food and Drug Administration (FDA) is tasked with reviewing and eliminating redundant regulations within 180 days to expedite the approval of domestic pharmaceutical manufacturing facilities.

• Enhanced Oversight of Foreign Producers: The FDA will increase inspections of overseas facilities to ensure they meet U.S. standards, aiming to level the playing field for domestic manufacturers.

• Accelerated Facility Construction: The Environmental Protection Agency is directed to expedite the permitting process for building pharmaceutical manufacturing plants in the U.S., addressing the current 5 to 10-year timeline deemed unacceptable for national security.

This executive order underscores a strategic pivot towards bolstering national security through domestic production of critical medicines. Healthcare organizations involved in pharmaceutical manufacturing, supply chain management, or regulatory compliance must assess their operations in light of these changes.

At Lanton Law, we specialize in guiding healthcare businesses through complex regulatory landscapes. Our expertise ensures your organization remains compliant and competitive. To understand how this executive order impacts your operations and to develop a proactive compliance strategy, contact us today.

Executive Action Targets High Drug Costs: What the Industry Needs to Know

On April 15, 2025, President Trump signed the executive order titled “Lowering Drug Prices by Once Again Putting Americans First,” signaling a significant shift in U.S. pharmaceutical policy. This directive aims to reduce prescription drug costs through a multifaceted approach, impacting various aspects of the healthcare industry.​

Key Provisions:

• Medicare Drug Price Negotiation: The order directs the Department of Health and Human Services (HHS) to enhance the Medicare Drug Price Negotiation Program. This includes prioritizing high-cost drugs and improving transparency to achieve greater savings for beneficiaries.​

• Alignment of Payment Structures: It proposes aligning Medicare payments for certain prescription drugs with the actual acquisition costs incurred by hospitals, potentially lowering prices by up to 35%. Additionally, the order seeks to standardize payments for treatments like cancer therapies, regardless of the care setting, which could reduce costs by as much as 60%. 

• Discounted Medications for Low-Income Patients: The executive order reinstates programs to provide insulin and injectable epinephrine at significantly reduced prices for low-income individuals and the uninsured, aiming to make these life-saving medications more accessible.

• Facilitation of Drug Importation: It instructs the FDA to streamline the approval process for state-run drug importation programs, potentially allowing states to source medications from countries like Canada to reduce costs.

• Acceleration of Generic Drug Approvals: The order calls for the FDA to expedite the approval of generic and biosimilar drugs, fostering competition and potentially leading to lower drug prices.

Implications for the Healthcare Industry:

While the executive order outlines ambitious goals, the industry is looking for additional details. The potential for new tariffs on imported pharmaceuticals, coupled with changes in Medicare payment structures, could disrupt supply chains and affect pricing strategies. Healthcare providers, pharmaceutical companies, and policymakers must navigate these changes carefully to mitigate risks and capitalize on opportunities.​

How Lanton Strategies Can Assist:

In this evolving policy landscape, Lanton Strategies offers strategic consulting and lobbying services to help clients understand and influence the implications of the executive order. Our expertise in healthcare policy and regulatory affairs positions us to provide targeted messaging and advocacy efforts, ensuring our clients' interests are represented before the Administration and Congress. Contact us to learn more about how we can help you navigate this period of change.​

Lanton Law Speaks with Pharmaceutical Executive on Navigating NIH Funding Cuts, Diversity Bans, and Tariff Challenges

Lanton Law spoke with Pharmaceutical Executive on NIH Funding cuts. The interview is titled “Navigating NIH Funding Cuts, Diversity Bans, and Tariff Challenges: Legal and Industry Implications for Medical Research”

The interview can be seen here.

Lanton Law Quoted in Pharmacy Times Interview on Drug Pricing Reforms Amid the Repeal of Executive Order 14087

Lanton Law was quoted in the Pharmacy Times Article titled "Reversal of Executive Order (EO) 14087 Raises Questions About Future Drug Pricing Reforms.” We discuss the EO and how pharmacists are impacted. The article can be viewed here.

Lanton Law Quoted in Pharmacy Times Article Titled "Mifepristone Has its Day in Court"

Lanton Law was quoted in Pharmacy Times article titled “Mifepristone Has its Day in Court.” The article discusses the drug amid its backdrop in the U.S. Supreme Court.

Lanton Law Quoted in Pharmacy Times Article "FDA Approves First Nonprescription Daily Birth Control Pill"

Lanton Law was quoted in the Pharmacy Times article titled “FDA Approves First Nonprescription Daily Birth Control Pill.” The article can be viewed here.

FDA REMS Change for Abortion Pill Creates Opportunities, Questions for Pharmacists

Although the FDA has now allowed retail pharmacies to dispense mifepristone, a drug used for medicated abortions, questions still remain about the requirements for pharmacies and the availability of the drug. Lanton Law talks to Pharmacy Times in an interview about a post Dobbs world with mifepristone. Click here for the interview.

Expert Discusses Long-Term Implications of Roe V. Wade Decision for Pharmacists, Contraception Access

In an interview with Pharmacy Times, Ron Lanton III, Esq, partner at Lanton Law, discussed the recent Supreme Court ruling on Dobbs v. Jackson Women’s Health and what this could mean for pharmacists. In the interview, Lanton said the decision leaves many things ambiguous, which will most likely result in litigation around the country in the coming weeks and months.

The interview can be viewed here. We have also provided the text from Aislinn Antrim’s interview at Pharmacy Times below:

In an interview with Pharmacy Times, Ron Lanton III, Esq, partner at Lanton Law, discussed the recent Supreme Court ruling on Dobbs v. Jackson Women’s Health and what this could mean for pharmacists. In the interview, Lanton said the decision leaves many things ambiguous, which will most likely result in litigation around the country in the coming weeks and months.

Aislinn Antrim: Hi, I'm Aislinn Antrim with Pharmacy Times,and I'm here with Ron Lanton, partner at Lanton Law, to discuss the recent Supreme Court decision in Dobbs v. Jackson Women's Health and what this means for pharmacists, contraception access, and all of these other questions. So to get started, can you explain the Supreme Court reasoning in this case?

Ron Lanton III, Esq: Absolutely. And before I get started, let me just put a disclaimer out there that while I'm not going to be discussing my personal views about the Supreme Court decision, I'm just going to talk like a lot of health care providers are probably talking right now, where they're just trying to figure out what happened, and what does this mean for them. So, with that out of the way, I'll quickly explained Dobb.

So basically, what happened in this case is that Roe v. Wade and Casey v. Planned Parenthood were both actually overturned by the Supreme Court on the basis that abortion at any time was not protected by the constitution. So basically, what they've done is that they didn't really put any standards around what they thought abortion was, or you know, how many weeks there should be at, because they felt that the state should actually control the outcome. So, the facts within Dobbs is that the state of Mississippi banned abortions at 15 weeks, which is pre-viability (viability referring to if the fetus can survive outside of the womb). And what Justice Alito said, writing for the majority opinion, is a quote that I wanted to make sure that everybody has heard in case they have not read the opinion. And the quote talks about this, it says, “The inescapable conclusion is that a right to abortion is not deeply rooted in the nation's history and traditions. On the contrary, an unbroken tradition of prohibiting abortion, on pain of criminal punishment, persisted from the earliest days of the common law until 1973.” So, this is definitely a landmark decision. You know, my entire life has been post-Roe. So, this is going to be very, very different for a lot of people and we'll see what happens.

Aislinn Antrim: Definitely. Where do states stand currently in terms of abortion access? And where do you see this headed in the coming weeks and months?

Ron Lanton III, Esq: I see a lot of litigation coming in the next weeks and months. Right now, it's kind of weird how we say this, because right now, there are 5 states where abortion is either illegal or banned. Those states are Texas, South Dakota, Oklahoma, Louisiana, and Kentucky. Soon there will be 16. And the reason I say that is because of what's called trigger laws. So basically, if Roe was ever overturned, which it was in this case, there were some states that have laws in the books that said, should this happen, then, you know, within 30 days abortions will be banned in that state.There is also another thing called zombie lawsthat are out there, in addition to the trigger laws, and what zombie laws are, is that these are pre-Roe abortion laws that may come back, they were never officially taken off of the books. So, they're just kind of there and a lot of states really don't know what to do with these and businesses that are operating there don't know what to do with these, or if they'll ever come back. So that number, while it may go up to 16 with the trigger laws, it may be more with these zombie laws. So, we really have to do a close scrutiny of what's on the books. And I think that if health care providers are wondering what that might be, I would just suggest that they look and see if their states do in fact have these laws on the books. There have been some states, though, that have taken the stance that they will be arresting medical providers that actually attempt to do these services. So, my prediction is just like I mentioned earlier, is that we're probably going to see a lot of different lawsuits, just for people that are trying to understand their rights and what they can and can't do, especially the health care providers.

Aislinn Antrim: Absolutely. There are many things that are still really unclear. One of the major things that's come into play is access to mail-order abortion pills, and from my understanding, the FDA has permanently allowed these pills to be accessible by mail. But some governors are still looking to ban them. Can you explain this, what this means, and where it stands?

Ron Lanton III, Esq: Yeah, of course. Well, the FDA has been using the pill since 2000, and in December of 2021 what they did was they had some labeling and some evidence-based medicine requirements that they put in and finalized in December of 2021. I can't really speak to specifics about what those are. I know they did them, but if people are interested, I would just go to the FDA and just look. They have that stuff there on their site. The FDA does allow the pill to be prescribed by mail or by telehealth and it's authorized for use during the first 10 weeks of pregnancy. And what was interesting was that when I was looking at this is that more than half of the abortions in the United States are actually medication abortions, which I did not know.

You have mentioned some of the anti-abortion policies that tend to happen with this. So, there have been some anti-abortion states that have laws on the books that stipulate that this pill either has to be given in-person or it has to be prescribed, instead of done through telehealth or by mail. And also, they're saying it's only allowed through the seventh week, whereby the FDA says that it's the tenth week. So that's different. So, what we're seeing here, and what we're also hearing, is that some states may even try to ban the pill. And there's questions legally on whether they can do this. It's really a Tenth Amendment versus Supremacy Clause question. You know, I don't think the FDA, this is just me personally, I think you should check this out. But you know, just for me, I'm not sure you could do that as a state, just legally, with something that the FDA has already approved. It's also going to come down to what the Board of Medicine in your particular state is allowing a physician to do. So, these are just other things that a health care provider would have to check out.

I do think it is interesting to bring up what the Department of Justice has said about this very issue. So, here's a quote I’d like to share with you. So, in what the Department of Justice has said, has stated, “…and we stand ready to work with other arms of the federal government that seek to use their lawful authorities to protect and preserve access to reproductive care. In particular, the FDA has approved the use of medication (Mifeprex). States may not ban this based on disagreement with the FDA’s expert judgment about safety and efficacy.” So, if a state has a policy where it's just challenging the safety of it, that's not going to stand. So, what really remains to be seen is if states are going to continue to do this regardless, we'll have to see.

Aislinn Antrim: Very interesting. And there are also states where legislators are attempting to interpret IUDs as abortion to restrict their access. What is the legal basis for this? And what are the implications if they are successful?

Ron Lanton III, Esq: Yeah, so let's go back to the Supreme Court majority opinion. In this case, they said that other rights, like the rights to contraception and marriage, do not discuss the ending of human life as abortion does. So, they tried to make a distinction in this ruling. Now, with what you just brought up, I started thinking about Plan B and copper IUDs because those stop an already fertilized egg or an embryo from implanting and thus creating the pregnancy. Right? So, the argument Dobbs was they sided with Mississippi in that Mississippi could deny an abortion at pre-viability, which they already ruled that they can. So, therefore, a state could potentially rule with regards to Plan B or the copper IUD, that these are not contraception and that they are a form of abortion. I mean, theoretically it could happen, as they stop an embryo from implanting, thus stopping human life. So especially if the state believes that human life starts at fertilization, and not implantation. So, many health care providers are definitely likely to be concerned about this because it could also affect IVF treatments. Basically, this ruling has allowed states to ban abortion but kind of has left the door open because they were ambiguous on, you know, they didn't say anything about weeks or what abortion was, there was no definition about it. So, this could potentially bleed over into contraception. So honestly, a legal basis for this could be a new law that describes when human life starts, such as fertilization instead of implantation. So, Dobbs opened the door to that and, you know, that's another one of those things we just don't know.

Aislinn Antrim: Definitely. Many people are urging the Biden administration and Congress to codify a right to abortion. Do you have a sense of whether this could happen or where this stands?

Ron Lanton III, Esq: Well, let's just talk about the Senate makeup right now. So, to get anything passed in Congress has been very difficult to do lately because of just the hyper-partisanship stuff that's been going on. And the Senate, it's almost like forget about it. You know, if you don't have those 60 votes to satisfy the threshold, then you're just not getting anything done. So right now, with an issue this divisive—and really, I mean, anything can be hyper-partisan but, you know, this is definitely one of those issues. I don't know if they can get anything passed in the Senate that could codify Roe.

Now, I like to go back to whether it's accurate when we say codify Roe, because Roe v. Wade hasn't been in place since 1992. And the reason I say that is because the Supreme Court had the Casey v. Planned Parenthood case that I referenced earlier, which was also overturned with Roe in the Dobbs decision. Now, in Casey, the court upheld Roe’s decision holding that a woman has the right to choose to terminate a pregnancy up until the point of fetal viability, and that states could restrict abortion after that point, subject to exceptions such as, you know, protecting the life and health of the pregnant woman. But in Casey the court said that Roe too severely limited state regulation prior to fetal viability and held that states can impose restrictions on abortion throughout pregnancy to protect potential life, as well as the maternal health, which, you know, which has been status quo up until just recently. What was also interesting about Casey is that had had the undue burden test, which basically said that states can't make a law that makes it too hard for someone that wants to seek an abortion. So again, that's been status quo until now. And now we're really not sure what's going to happen.

Aislinn Antrim: Definitely. Going back to what you were saying a few minutes ago, there are also discussions of whether a future Supreme Court case could impact contraception access. What could this look like from a policy or legal standpoint?

Ron Lanton III, Esq: I think [policy and legality] these are 2 related issues, but when we're looking at legalities, I mean, you know, we can split hairs all day but those legally are 2 different issues. So, for contraception that prevents fertilization, you know, such as the pill, that would require a state to draft an entirely new law that outlawed contraception. And that would have to be pushed through several states, and then in order to get to the Supreme Court, someone would have to challenge that and make it all the way up through the ladder. So, these cases are coming faster than they used to before, but that's the process that would have to happen. The rights of contraception is a bit different than what we were talking about in Dobbs because the contraception was actually a different case based on Griswold v. Connecticut. And that basically held that married couples have a protected right to privacy, and that this is being violated by states banning contraception. So, Griswold was not overturned or even mentioned in the majority opinion. Now, I think what has people talking is the Justice Thomas concurring opinion, which basically said that we ought to look at cases like Griswold. Well, that's different from the majority opinion. So, the majority opinion is what we base everything off of now. Concurring opinions happen, judges put their opinions in there all the time. Whether someone later may look at that concurring opinion and shape a different policy, legally or whatnot, that remains to be seen. But the majority opinion did not talk about Griswold. I just want to make sure that was very clear.

Aislinn Antrim: Definitely. Thank you. Could this Dobbs ruling potentially impact the legality of scientific research and innovation in the area of women's health and contraception?

Ron Lanton III, Esq: Yes. So, any current or future research that is connected to the use of an already fertilized egg or an embryo may be deemed unlawful by a state, depending on what their abortion laws actually are. So, as we talked about earlier, Dobbs opens the door for states to determine when human life actually begins. And they're now able to put in their own standards about how they feel about abortion. So, I think in order to answer your question, it really depends on how the state is going to regulate the practice of medicine. So, it’s going to come down to where you live and how medicine is regulated.

Aislinn Antrim: With a wide range of restrictions varying state-to-state, do you have any resources or suggestions for pharmacists who may not know exactly how to handle things in their state, what's legal what they can and can't do? Where can they look?

Ron Lanton III, Esq: That's a good question. I think if I were a pharmacist in this environment, I would definitely look at the Board of Pharmacy to see if there's any guidance about that. I think the second thing that you have to do is really understand how Plan B is going to be regulated. And I think if that's the case, you might want to call an attorney—I'd hate to even get to that kind of level, but you want to make sure that you're complying with what is going on. But I think an issue that most people miss is privacy and HIPAA. And, you know, if you have someone that's coming to a pharmacy that is in a state like the Northeast, where it's pretty much status quo with how they're going to rule or regulate this issue, you know, you can't be telling another state what's going on based on that. So, you really should understand your privacy laws and just look at that in your state. And just make sure you have a good understanding of HIPAA, which will help you in your practice going forward. So, I think those are the 3 places that I would look at first, to make sure. So, make sure that you understand your privacy, get a lawyer if you have questions about things, and just make sure that you're familiar with Board of Pharmacy and their policies and procedures.

Aislinn Antrim: Absolutely. Well, we've covered a lot. Is there anything that you wanted to add?

Ron Lanton III, Esq: I wish I could, I wish I had a crystal ball to kind of figure out how all this is going to go. Like I said, I think with this decision it's going to be a lot of litigation. So, this is not going to be over by, you know, any short imagination. This is going to go on for quite a while. And the only thing that could change things again, back to the way things were, is either an act by Congress, which would invalidate a court decision, or this comes back up through the Supreme Court again and they rule a different way. So that's a long way of me saying that we just have to wait and see what happens.

Aislinn Antrim: Absolutely. Well, thank you so much for diving into this with me.

Ron Lanton III, Esq: You’re welcome, thank you for the time.

Pharmacy Times Speaks with Lanton Law About "Vanity Drugs"

In an interview by Aislinn Antrim of Pharmacy Times called “Calling Them ‘Vanity Drugs,’ Some Insurers Refuse to Cover New Anti-Obesity Drugs,” Ron Lanton III, Esq., Partner at Lanton Law, discussed why insurers are refusing to cover new, highly effective anti-obesity drugs and how some prescribers are getting around the issue. Lanton said that this is a common issue across many different disease spaces and drug types, but some policy changes may be able to help.

The interview can be seen here.

We have taken the text that appears on Pharmacy Times.com from the interview and placed it below in case you have trouble accessing the video.

Aislinn Antrim: Hi, I'm Aislinn Antrim with Pharmacy Times, and I'm here with Ron Lanton, principal at Lanton Law, to discuss how and why some insurers are considering new weight loss and anti-diabetes drugs to be “vanity drugs.” So, there are several new drugs on the market, and they've shown significant weight loss in clinical trials. But some insurers are calling these “vanity drugs” and are not covering them. Do you have a sense of what this term, vanity drugs, means?

Ron Lanton III, Esq.: No, I don't. I think whenever somebody askd me, like, “What does that mean?” I’m always like, okay, let's go to the legal definition. And I don't think there really is a legal definition of vanity drugs, which is something that we say. But to me, whenever I hear something like that characterized as vanity drugs, it's just another excuse. We're not going to pay for it. Right? So, I got a couple of ideas about what I think is going on behind that terminology, but I just wanted to talk a little bit about what this drug is and kind of the history about why it got here and where we are.

So, the brand name drug is Wegovy, because it's just too complex for me to say the generic form of the name of it, but it was approved last year in June by the FDA. And apparently, this is a new generation of highly effective hormone-based obesity medications. And specifically, what it does is that it targets a hormone, GLP-1, which is secreted in the gut, and then targets receptors throughout the body. And it makes it so that there is some kind of positive response, where you do lose the weight. And for this drug, it was prescribed for patients that are obese, who have a BMI or body mass index of greater than 30, or a BMI greater than 27 accompanied by weight-related medical problems, such as high blood pressure and type 2 diabetes and cholesterol, things like that. It’s definitely something that I believe would be beneficial to the patient because if you do take it, if it works as it says, we're not going to jump to those other more expensive disease states that cost a lot of money to treat.

But, going back to like the whole vanity drug classification of it, yes, this isn't a proven curative drug, I think they were saying like up to 13% of individuals don't lose any weight that take this drug. But, you know, insurance companies have for a while used thing called step therapy, where they're like, try drug A first before you go to drug B, and a lot of time is wasted. And a lot of dollars can be wasted too, because that's that kind of one-size-fits-all approach to everything. Whereas, you know, if we're doing more curative, something that just kind of goes right to your specific biological makeup, that could have a lot better of an outcome for a patient and at a lower cost. So, I think they're coming at it from a step therapy mindset.

And, too, there is a policy that's been weakened a little bit ago by the court, but the copay accumulator, where they're stopping you from having the rebates from a manufacturer go to the deductible and the patient's maximum allowable cost. So, it's like you have those mindsets of let's try not to pay it. But I think, you know, with our medicine and science getting a lot better, we're going to have to think past that old traditional reimbursement system.

Aislinn Antrim: Yeah, absolutely. This seems to be kind of a widespread issue—you talked about Wegovy, and it's been applied to a couple of these other similar new drugs. What are pharmaceutical lobbyists really doing to kind of get insurers to pay for these?

Ron Lanton III, Esq: That's an interesting question. So, I can't speak for pharma, I don't know what they're doing. I talked to pharma interests, I did look at their website, and one of their policy issues is called “Build a better patient-centered agenda.” And I like where they're going with that, because essentially, what it's saying is we want insurance to work like insurance is supposed to work. Which is, if we have something that's wrong with us, we go see the doctor, the doctor prescribes. And the doctor says, “This is what we think is good for that patient to have a good outcome.” And the insurance is supposed to just pay for it. Now, you know, there's all kinds of things, and I know why there's rules about it and there's all kinds of special circumstances. But you know, more times than not, we're fighting the insurance company to pay for things that seem to be common sense. So, I think there is a bill, which I'll talk about in a little bit, on the obesity issue that we're talking about here. But instead of it being what I call a hard lobbying issue, which is I'm going to go directly to my congressman, or my senator and we'll go lobby about how we need this particular drug. It seems to be more of a soft lobbying issue to me, where the pharmaceutical industry would have to reach out to the payers to have that conversation about why the manufacturers think this is a good thing with the patients today. They have to talk to the patient themselves and educate the patient. So, if the patient feels comfortable enough, what you're dealing with is years of stigma and everything about this. Again, this is getting out of traditional health care and going to the root of the problem. And instead of just treating a symptom, you know, we're really trying to figure out what's going on here. So that's the other thing. And then really, the last thing that I see as kind of the soft lobbying by pharma is educating the doctors about this drug and why this is here, and why they should start to utilize this in their weapons system of fighting whatever it is that they're dealing with patients. So that's what I call more of a soft lobbying issue.

Aislinn Antrim: Interesting. Are there policy changes that could address this issue?

Ron Lanton III, Esq: The court system is weakening the copay accumulators, which I mentioned earlier, and there have been several state and state efforts. And, definitely, there's a federal bill right now on step therapy, where they're trying to get rid of that, because again, it's like, why are we doing all these things that may not work, and it's wasting time and it's causing a lot of money. And we could just get right to the heart of the problem, especially when the doctors are saying, you really shouldn't get in between my relationship with my patient, because I know the patient. And, you know, I'm the closest that's here. So, this is what I think.

There is an interesting bill that I want to bring up about policy changes that you had asked about. So, there is a bill, HR 1577, and there's also a senate version of this—SB 596 is a companion bill. So it’s basically the same bill that's in the house is also in the Senate, same language, and everything. It’s called the Treat and Reduce Obesity Act and let me tell you just really quick what this is. The bill would allow for coverage for therapy that is provided by a physician who's not a primary care physician, or other health care providers and approved counseling programs, if you have a referral from your PCP. Currently, the therapy is covered only if provided by a PCP. The bill would also allow coverage under Medicare's prescription drug benefit, so under Part D, for the treatment of obesity, or weight loss management for individuals who are overweight. So, this really targets what we're talking about right now. And if we actually have this bill go through, I think this conversation will be a lot easier, because we already have the regulatory scheme for it, instead of having to build it from scratch and just kind of convince people that this is a good thing for patients to take. Again, when we're coming at it from the traditional mindset of “Let's try not to pay for things and if we do, let's try the cheaper stuff first, before we get to something that might actually help,” I think that's just backwards.

Aislinn Antrim: Yeah, absolutely. Do you see similar issues in other drug classes or treatment areas?

Ron Lanton III, Esq: A long while ago—well, it's about 2013, so seems like a long while ago, with everything that's happened between then—[we had] Sovaldi with hepatitis C, you know, at $4,000. For the treatment, I think it was 12 course treatment, and people were like, “Oh, my God.” I know there's still an issue but, you know, if 9 out of 10 times a patient takes this, they get better, those are pretty decent odds. So why not try it for a little bit? So, that would be my kind of form of step therapy, which is let's just try, and if it's not working, then okay, we can get off of it. But this kind of seems to be what I call a best-in-breed prescription out there. So, like, if this is the best thing, let's take it and see what happens. And I think, again, with drugs that are curative and more expensive, because the upfront cost has to be there, because you're not going to have the repeat customer because they're getting cured. But at the same time, I think somebody has to do a cost analysis at the payer by saying, if we put patient on drug A and it costs this, but if we put them on drug B, it's going to cost all this other stuff and the patient's going to get sicker. It's just that's just not really what we should be doing. I do know that there's this balance of, you know, we have to have something that's affordable for patients to take. So it's $84,000. And I hate to bring up old wounds, but it's at $4,000, something that is reasonable or not. And I think that's, you know, something that the pharma and the insurance just still haven't quite worked out yet, especially since we keep seeing this thing about drug price from congress, and why is this stuff so high? But I think now there's a lot more scrutiny starting to come into the picture with the Federal Trade Commission, and how they're now saying, okay, well, high drug prices and what are these PBMs doing and let's find out a little bit more about this. So, that's something we should continue to watch. But those are the policies. You know, if we get bills like this, we have an FTC that is really scrutinizing both pharma and the PBM industry, I think we'll start to slowly but surely get to an answer that's tolerable for everybody.

Aislinn Antrim: Well, that's good to hear. Some companies have found kind of an interesting workaround by marketing these drugs as diabetes treatments, rather than weight loss drugs. And in some cases that seems to have worked. Does this seem like an effective solution? Or what are your thoughts on this?

Ron Lanton III, Esq: I think it obviously depends on what the doctor is seeing from the patient. I mean, if you're pre-diabetic, then you know, if you don't do anything, you're going to get over into type 2 diabetes, potentially. So, I can understand the rationale behind it. But I don't think it's really that different than off labeling. I mean, you know, if you have a drug and it's supposed to be used for cancer A but also works for cancer B, it’s not approved for cancer B, but, you know, there may be times as a patient where your condition doesn't have something that is FDA approved, but the doctor is looking at these studies and trying to see what can help you. Again, that's that patient-doctor relationship that you just have to trust. And that's what the patient is looking for. So, I think it's really no different than off labeling and if that really goes to the result that we're getting to, I'm all for it.

Aislinn Antrim: Absolutely. Why do list prices vary for the same drug with different indications? So, with diabetes versus for obesity?

Ron Lanton III, Esq: Yeah, that's the million-dollar question. Literally, if you live with these high-priced drugs, right? I don't know if I can give you an answer. I think the best people to ask this question to would be the pharmacy benefit managers, because the more and more they've gotten involved, the more and more prices have gone up. And that is because the manufacturer has to hire the higher price because they have to compensate for the rebate that they're giving to the pharmacy benefit manager. So why is that? And I think that, you know, like I was telling you earlier, the scrutiny with the Federal Trade Commission going in and just seeing exactly what PBMs are doing with these drug prices, and then, you know, either getting some federal standards around it, and what they can and can't do or be giving the PBM a federal regulator. They don't have one, you know, and it's just this piecemeal stuff that they're doing by state. I think those days are numbered, as far as just having a PDMP and unregulated entity. But I think the more layers that start to get peeled back, the more attention that's coming. Again, this stuff doesn't happen overnight. None of this happened overnight at all. I mean, PBMs really didn't grow until the ‘90s. So, we're talking from the ‘90s until now, there's been some changes, gradual changes, but there's been a shift. And I think we're starting to start to shift that backwards to where we can get an answer. We'll find out these things.

Aislinn Antrim: Wonderful. Is there anything else you wanted to add on this topic?

Ron Lanton III, Esq: No. I think this is definitely not the last thing that we're going to see. I just think it's, I hate to say it, I know it's a different disease state, but it's just Sovaldi in a different form. I mean, we have these drugs that are promising to do things, and if 13%—and I know that's one study, but I mean, if somebody tells me “Okay, 13% of people this may not do anything for them.” I'm at least willing to give it a shot, because it's better than what we have now. And it's definitely better than some of the step therapy protocols that patients are going to have to go through.

Aislinn Antrim: Definitely, thank you for talking to me about this.

Ron Lanton III, Esq: Definitely. Thank you for asking.

FDA Releases Draft Guidance To Encourage Enhancing Clinical Trial Diversity

The FDA has just released draft guidance in the Biden Administration’s effort to encourage the industry to enhance clinical trial diversity. 

The purpose of this guidance is to provide recommendations to sponsors developing medical products2 on the approach for developing a Race and Ethnicity Diversity Plan (henceforth referred to as the “Plan”) to enroll representative numbers of participants from underrepresented racial and ethnic populations in the United States, such as Black or African American, Hispanic/Latino, Indigenous and Native American, Asian, Native Hawaiian and Other Pacific Islanders, and other persons of color, in clinical trials.3 Individuals from these populations are frequently underrepresented in biomedical research despite having a disproportionate disease burden for certain diseases relative to their proportional representation in the general population.

Adequate representation of these populations in clinical trials and studies supporting regulatory submissions helps ensure that the data generated in the development program reflect the racial and ethnic diversity of the population expected to use the medical product if approved, and may potentially identify effects on safety or efficacy outcomes that may be associated with, or occur more frequently within these populations.

The draft guidance can be found here.  

Lanton Law is a national healthcare and life science boutiquelaw andgovernment affairs firm that closely monitors legislative, regulatory and legal developments for our clients. Our life sciences practice can help stakeholders understand what’s at issue so that we can help our valued clients reach their goals.Contact us to learn about how either ourlegal orlobbying services can help you attain your goals.

FDA Releases Draft Cybersecurity Guidance

The FDA has just released a new cybersecurity draft titled “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions; Draft Guidance for Industry and Food and Drug Administration Staff; Availability.” The draft guidance can be viewed here. Comments are due July 7, 2022. 

What is the FDA proposing? 

In 2018, the FDA proposed updates to the final guidance, ‘‘Content of Premarket Submissions for Management of Cybersecurity in Medical Devices,’’ and issued a draft guidance of the same name.”

This draft guidance replaces the aforementioned 2018 guidance and is “intended to further emphasize the importance of ensuring that devices are designed securely, are designed to be capable of mitigating emerging cybersecurity risks throughout the Total Product Life Cycle, and to clearly outline FDA’s recommendations for premarket submission content to address cybersecurity concerns.” 

Why is the FDA doing this? 

According to the draft guidance as “more medical devices are becoming interconnected, cybersecurity threats have become more numerous, more frequent, more severe, and more clinically impactful. As a result, ensuring medical device safety and effectiveness includes adequate medical device cybersecurity, as well as its security as part of the larger system.”

How Lanton Law can help

Society’s reliance on technology has become even more vital with the effects of COVID-19. With all of the hacking and malware attacks we have witnessed against various data stakeholders, we foresee cybersecurity as a major legal & policy area that will continue to be expanded.   

Lanton Law is a national boutique law and lobbying firm that focuses on technology and healthcare. If you are a tech or healthIT industry stakeholder with questions about the current landscape or if you would like to discuss how your organization’s strategic initiatives might be impacted by either Congress, regulatory agencies or legal decisions, contact us today.

FDA Proposes Rule Impacting Wholesale Drug Distributors & 3rd Party Logistics Providers

According to the Food and Drug Administration proposed rule, the (FDA) is “proposing national standards for the licensing of prescription drug wholesale distributors (“wholesale distributors” or “wholesale drug distributors”) and third-party logistics providers (“3PLs”), as directed under the Drug Supply Chain Security Act (DSCSA) (Title II of the Drug Quality and Security Act). Pursuant to the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the DSCSA, the proposed rule would establish standards for all State and Federal licenses issued.”

The rule can be found here. The comment period ends June 6, 2022. 

Lanton Law has personal experience in the wholesale distribution industry. 

Lanton Law is a national healthcare and life science boutique law and government affairs firm that closely monitors legislative, regulatory and legal developments for our clients. Our healthcare practice can help distribution stakeholders understand what’s at issue so that we can help our valued clients reach their goals. Contact us to learn about how either our legal or lobbying services can help you attain your goals.   

Lanton Law’s publications should not be construed as legal advice on any specific facts or circumstances. The contents are intended for general information purposes only and may not be quoted or referred to in any other publication or proceeding without prior written consent of us. To request reprint permission for any of our publications, please use our “Let’s Chat” form, which can be found on our website at www.lantonlaw.com. The mailing of this publication is not intended to create, and receipt of it does not constitute, an attorney-client relationship.

Prescription Digital Therapeutics (PDTs) Legislation Introduced

The Access to Prescription Digital Therapeutics Act of 2022 has been introduced by  Reps. Mike Thompson (D-CA) and David McKinley (R-WV) and Sens. Jeanne Shaheen (D-NH) and Shelly Moore Capito (R-WV). 

“According to the bill’s release, it would expand Medicare coverage to include PDTs, which are software-based treatments designed to directly treat disease, tested for safety and efficacy in randomized clinical trials, evaluated by the U.S. Food and Drug Administration (FDA), and prescribed by health care providers. PDTs are designed and tested much like traditional prescription drugs but rather than swallowing a pill or taking an injection, patients receive cognitive therapy through software.” 

The bill sponsors released a one page fact sheet about the bill and PDTs itself.

“Prescription Digital Therapeutics (PDTs) are software-based disease treatments designed to directly treat disease, tested for safety and efficacy in randomized clinical trials, evaluated by the FDA, and prescribed by healthcare providers. These therapies are designed and tested much like traditional prescription drugs with one distinction: rather than swallowing a pill or taking an injection, patients are treated with software.

The COVID-19 pandemic and public health emergency rapidly accelerated the pace of innovation to address some of the most pressing challenges in health care. New tools are being rapidly deployed and adopted, particularly in the case of digital health, which are increasingly being used, PDTs provide clinicians and patients with evidence-based remote treatment modalities to treat substance and opioid use disorders, mental health, diabetes and other diseases and conditions. However, there is no clear statutory benefit category to allow for Medicare and Medicaid coverage for PDTs.”

Lanton Law is a national healthcare and life science boutique law and government affairs firm that closely monitors legislative, regulatory and legal developments for our clients. Our HealthIT practice can help stakeholders understand what’s at issue with topics like digital therapeutics, RTM and RPM so that we can help our valued clients reach their goals. Contact us to learn about how either our legal or lobbying services can help you attain your goals.

New Congressional CBD Bill Introduced to Give Policy Clarity for CBD Products

Congress has introduced the bi-partisan CBD Product Safety and Standardization Act “that will establish federal standards for CBD food and beverage products to protect consumers and provide marketplace stability for farmers, producers, and retailers.” The bill is sponsored by U.S. Representatives Rice (NY-04), Griffith (VA-09), Craig (MN-02), and Crenshaw (TX-02).

According to the bill’s press release: 

“While the 2018 Farm Bill removed hemp-derived cannabidiol (CBD) from the Controlled Substances Act, it did not make changes to existing Food and Drug Administration (FDA) law or regulatory policies governing its use in FDA-regulated products. Since then, the market for CBD products has exploded, and CBD is ubiquitously available to consumers in oils, cosmetics, supplements, and foods, and it is even marketed in products for pets. The discrepancy between the Controlled Substances Act and FDA law has created a regulatory gray area in which CBD is widely available but unregulated – and considered illegal – by FDA. 

The bipartisan CBD Product Safety and Standardization Act would allow FDA to regulate CBD as it would any other food ingredient and subject these products to enforceable safeguards to ensure accountability. It also charges the agency with establishing CBD content limits and packaging and labeling requirements and determining in which categories of food CBD is appropriate for use. This bill will help distinguish responsible players from bad actors that ignore federal requirements for quality, manufacturing, labeling, and claims, and it will bring safety and clarity to the market.”

Lanton Law is a national boutique law and lobbying firm that focuses on healthcare/life sciences and technology. Specifically we have expertise in cannabis and CBD related issues.

If you are an industry stakeholder with questions about the current landscape or if you would like to discuss how your organization’s strategic initiatives might be impacted by either Congress, regulatory agencies or legal decisions, contact us today.

FDA Approves First Interchangeable Biosimilar for Humira

According to the FDA’s press release, “The U.S. Food and Drug Administration approved the first interchangeable biosimilar product to treat certain inflammatory diseases. Cyltezo (adalimumab-adbm), originally approved in August 2017, is both biosimilar to, and interchangeable with (may be substituted for),  its reference product Humira (adalimumab) for Cyltezo’s approved uses. Cyltezo is the second interchangeable biosimilar product approved by the agency and the first interchangeable monoclonal antibody. Once on the market, approved biosimilar and interchangeable biosimilar products can play a role in facilitating access to treatments for many serious health conditions.” 

Furthermore, “The FDA granted approval of Cyltezo to Boehringer Ingelheim on October 15, 2021. To date, the FDA has approved 31 biosimilar products, including two interchangeable products, for a variety of health conditions.”

The FDA’s announcement can be viewed here. 

This is an exciting announcement by the FDA, as competitors to the originator now have a viable path forward to make market inroads. 

Lanton Law is a national healthcare and life science boutique law and government affairs firm that closely monitors legislative, regulatory and legal developments for our clients. Our life sciences practice can help stakeholders understand what’s at issue so that we can help our valued clients reach their goals. Contact us to learn about how either our legal or lobbying services can help you attain your goals.  

Latest FDA Refusal to Approve CBD as a Food Ingredient or Supplement Causes Stakeholder Frustration

The federal Food & Drug Administration (“FDA”) has refused to consider an application by Charlotte’s Web Holdings, Inc. (“Charlotte’s Web”) for a CBD product to be sold as a dietary ingredient. This decision was outlined in an FDA letter to the company found here.

“Under 21 U.S.C. § 350b(a), the manufacturer or distributor of a dietary supplement containing a new dietary ingredient that has not been present in the food supply as an article used for food in a form in which the food has not been chemically altered must submit to FDA, at least 75 days before the dietary ingredient is introduced or delivered for introduction into interstate commerce, information that is the basis on which the manufacturer or distributor has concluded that a dietary supplement containing such new dietary ingredient will reasonably be expected to be safe. FDA reviews this information to determine whether it provides an adequate basis for such a conclusion. Under 21 U.S.C. § 350b(a)(2), there must be a history of use or other evidence of safety establishing that the new dietary ingredient, when used under the condition recommended or suggested in the labeling of the dietary supplement, will reasonably be expected to be safe. If this requirement is not met, the dietary supplement is considered to be adulterated under 21 U.S.C. § 342(f)(1)(B) because there is inadequate information to provide reasonable assurance that the new dietary ingredient does not present a significant or unreasonable risk of illness or injury.

FDA has carefully considered the information in your notification and other available information and determined that your NDI 1202 cannot be used in dietary supplements pursuant to the dietary supplement exclusion provision in 21 U.S.C. § 321(ff)(3)(B) (section 201(ff)(3)(B) of the Act). The definition of a dietary supplement is set forth in 21 U.S.C. § 321(ff) (section 201(ff) of the Act), which states in relevant part:

(ff) The term ‘dietary supplement’ . . . (3) does . . . (B) not include – (i) an article that is approved as a new drug under section 355 of this title . . . or (ii) an article authorized for investigation as a new drug . . . for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public,

which was not before such approval . . . or authorization marketed as a dietary supplement or as a food unless the Secretary, in the Secretary's discretion, has issued a regulation, after notice and comment, finding that the article would be lawful under this chapter.

FDA has concluded that CBD products are excluded from the dietary supplement definition under 21 U.S.C. § 321(ff)(3)(B) (section 201(ff)(3)(B) of the Act).

We also conclude that, even if your NDI 1202 was not excluded from the definition of dietary supplement, the agency has concerns about the adequacy of safety evidence included in your submission as a basis for concluding that a dietary supplement containing NDI 1202 will reasonably be expected to be safe under the conditions of use described in your notification.”

Many in the industry were hoping to get some additional clarity on how FDA would oversee CBD and whether FDA’s views have evolved. Unfortunately that is not the case yet. CBD continues to be an item that has an uneven regulatory scheme. 

Lanton Law is a national boutique law and lobbying firm that focuses on healthcare/life sciences and technology. Specifically we have expertise in cannabis and CBD related issues.

If you are either thinking about or are currently selling CBD and are unsure how your business model fares, contact Lanton Law so that we can go over your business model, assess potential risks and help you plan for both pending legislative and regulatory actions.

New Congressional Cannabis/Marijuana Bill Introduced

Senators Dianne Feinstein (D-Calif.), Chuck Grassley (R-Iowa) and Brian Schatz (D-Hawaii) have introduced the Cannabidiol and Marijuana Research Expansion Act. This proposed legislation seeks to improve the process for conducting valid medical research on marihuana, and to streamline the development of safe and effective FDA-approved medicines. The bill is cosponsored by Senators Dick Durbin (D-Ill.), Amy Klobuchar (D-Minn.), Thom Tillis (R-N.C.), Tim Kaine (D-Va.), Joni Ernst (R-Iowa), Jon Tester (D-Mont.) and Lisa Murkowski (R- Alaska). A one page summary of the proposal can be found here.  

Lanton Law is a national boutique law and lobbying firm that focuses on healthcare/life sciences and technology. Specifically our cannabis practice helps all supply chain entities from growers, financiers, suppliers, dispensers to ancillary services.

If you are an industry stakeholder with questions about the current landscape or if you would like to discuss how your organization’s strategic initiatives might be impacted by either Congress, regulatory agencies or legal decisions,contact us today.