Ron Lanton 12/19/25 Ron Lanton 12/19/25

Lanton Law Speaks with Drug Topics on Its Over the Counter Podcast on MFN

Lanton Law speaks with Drug Topics on their podcast episode of Over the Counter. Ron discusses developing policy expected to enact significant change in the pharmacy industry and beyond titled “Most Favored Nation: Global Benchmarking to Reimagine US Drug Distribution.”

Ron Lanton of Lanton Law speaks with Drug Topics on their podcast episode of Over the Counter. Ron discusses developing policy expected to enact significant change in the pharmacy industry and beyond titled “Most Favored Nation: Global Benchmarking to Reimagine US Drug Distribution.” Click here to access the podcast.

Ron Lanton 8/28/25 Ron Lanton 8/28/25

Can America's Retreat On mRNA Be Europe's Opportunity?

With the unprecedented success of mRNA vaccines during the pandemic, it almost felt as though mRNA technology was about to enter a “golden era” where new solutions using this platform would be found to finally address costly and devastating diseases that had been wreaking havoc in many countries. Unfortunately, the steadfast rising skepticism in the U.S. about vaccines has caused a drastic change on mRNA from the U.S. Department of Health and Human Services (HHS).

Lanton Law has an article in Life Science Connect’s Advancing RNA titled “Can America's Retreat On mRNA Be Europe's Opportunity?”

To view the article click here.

Ron Lanton 8/24/25 Ron Lanton 8/24/25

Lawsuits Likely as Federal Authorities Roll Back Longstanding Vaccine Guidelines

In a recent interview with Pharmaceutical Executive, Ron Lanton, partner, Lanton Law, discussed the unprecedented legal and policy challenges emerging from recent changes to federal vaccine recommendations.

Ron Lanton 6/7/25 Ron Lanton 6/7/25

Lanton Law Talks to Applied Clinical Trials About The Hidden Impact of Drug Pricing on Government Clinical Trials

In part one of this video interview, Ron Lanton III, Esq., partner, Lanton Law, discusses how a potential increase in drug costs could affect the clinical research industry.

In part one of this video interview, Ron Lanton III, Esq., partner, Lanton Law, discusses how a potential increase in drug costs could affect the clinical research industry. The interview can be seen here.

Ron Lanton 4/22/25 Ron Lanton 4/22/25

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.

Ron Lanton 1/28/25 Ron Lanton 1/28/25

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.

Ron Lanton 5/2/24 Ron Lanton 5/2/24

FTC, DOJ and HHS Extend RFI on Private Equity Control in Health Care Markets

The Federal Trade Commission, the Department of Justice’s (DOJ) Antitrust Division, and the U.S. Department of Health and Human Services (HHS) are extending the deadline by 30 days for the public to comment on a tri-agency Request for Information (RFI) examining private-equity and other corporations’ increasing control over health care markets. The new deadline is now June 5, 2024.

At Lanton Law not only do we understand the issues, but we provide you with timely solutions to help you make informed decisions about either an acquisition target or ways to maximize value. We counsel clients by performing corporate due diligence, provide strategic advice for growth and business strategies as well as structuring and executing M&A transactions.

Ron Lanton 8/29/23 Ron Lanton 8/29/23

Biden Administration Announces First Ten Drugs Selected for Medicare Price Negotiation

The Biden Administration has announced today that Medicare will be able to negotiate drug prices for the first time due to provisions within the Inflation Reduction Act.

The first ten selected drugs for negotiation are Eliquis, Jardiance, Xarelto, Januvia, Farxiga, Entresto, Enbrel, Imbruvica, Stelara and Fiasp.

The Administration stated that these drugs “accounted for $50,5 billion in total Part D gross covered prescription drug costs. The negotiations will occur in 2023 and 2024 and any negotiated prices will become effective beginning in 2026.

According to HHS press release read here, “In future years, CMS will select for negotiation up to 15 more drugs covered under Part D for 2027, up to 15 more drugs for 2028 (including drugs covered under Part B and Part D), and up to 20 more drugs for each year after that, as outlined in the Inflation Reduction Act.”

Lanton Law is a national boutique law and government affairs firm that closely monitors legislative, regulatory and legal developments in the healthcare and life science spaces. Contact us to learn about how either our legal or lobbying services can help you attain your goals.

Ron Lanton 6/7/21 Ron Lanton 6/7/21

NCPA Files Lawsuit on Pharmacy Direct & Indirect Remuneration (DIR) Fees

The National Community Pharmacists Association (NCPA) has filed a lawsuit against the U.S. Department of Health & Human Services (HHS) on DIR fees. Specifically, the complaint seeking declaratory and injunctive relief seeks three things according to NCPA’s release:

The rule’s definition of “negotiated price” violates the plain language and intent of Congress when they passed legislation creating the Medicare Part D program.
The rule is invalid as arbitrary and capricious. In 2014 CMS said that the “reasonably determined” exception leading to DIR fees would be “narrow,” but comment letters showed that not to be the case.3 A recent study showed that pharmacy DIR fees have increased 1600% since 2015, with $4 billion in DIR fees being squeezed from pharmacies in 2017 alone.
The Final Rule Was Not Adopted Through Proper Notice-and-Comment Rulemaking. The proposed rule defined negotiated prices to include all price concessions from pharmacies and did not discuss or address any exceptions. In the final rule, without giving interested parties notice or the opportunity to comment, CMS created the exception for price concessions that could not be reasonably determined at the point of sale.

HHS did file a motion to dismiss available here.

Lanton Law will continue to monitor the developments of this important case.

Lanton Law is a national boutique law and lobbying firm that focuses on healthcare/life science and technology. Our pharmacy practice has been helping pharmacies nationwide with operational issues, mergers and acquisitions, regulatory inquiries, audits, licensure, employment issues and contracting. Our lobbying entity (Lanton Strategies) is helping pharmacies nationwide achieve improved business climates through carefully crafted legislation.

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.

Ron Lanton 3/18/21 Ron Lanton 3/18/21

HHS Delays Rebate Rule to 2023 Due to a Court Order

Health and Human Services (HHS) has announced that the Trump administration’s directive that would have implemented the drug rebate rule against pharmacy benefit managers (PBMs).

According to the final rule:

“As required by an order issued by the U.S. District Court for the District of Columbia, this action provides notice of the delay of the effective date of certain amendments to the safe harbors to the Federal anti-kickback statute that were promulgated in a final rule (“Fraud And Abuse; Removal of Safe Harbor Protection for Rebates Involving Prescription Pharmaceuticals And Creation of New Safe Harbor Protection for Certain Point-of-Sale Reductions in Price on Prescription Pharmaceuticals and Certain Pharmacy Benefit Manager Service Fees”) published on November 30, 2020. The new effective date for these certain amendments is January 1, 2023.”

Lanton Law is a national boutique law and lobbying firm that focuses on healthcare/life science and technology. 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.

Ron Lanton 7/27/20 Ron Lanton 7/27/20

New Executive Order Aimed at Pharmacy Benefit Managers (PBMs)

The White House has released an Executive Order titled “Executive Order on Lowering Prices for Patients by Eliminating Kickbacks to Middlemen.”

“One of the reasons pharmaceutical drug prices in the United States are so high is because of the complex mix of payers and negotiators that often separates the consumer from the manufacturer in the drug-purchasing process. The result is that the prices patients see at the point-of-sale do not reflect the prices that the patient’s insurance companies, and middlemen hired by the insurance companies, actually pay for drugs. Instead, these middlemen — health plan sponsors and pharmacy benefit managers (PBMs) — negotiate significant discounts off of the list prices, sometimes up to 50 percent of the cost of the drug.”

This Executive Order advocates for HHS to complete its prior January 2019 proposed rule aimed at “revising the discount safe harbor to explicitly exclude from the definition of a discount eligible for safe harbor protection certain reductions in price or other remuneration from a manufacturer of prescription pharmaceutical products to plan sponsors under Medicare Part D, Medicaid managed care organizations as defined under section 1903(m) of the Act (Medicaid MCOs), or pharmacy benefit managers (PBMs) under contract with them.”

Not only does this Executive Order state that discounts offered on prescription drugs should be passed on to patients, but that HHS must confirm publicly prior to finalizing its proposed rule that “that the action is not projected to increase Federal spending, Medicare beneficiary premiums, or patients’ total out-of-pocket costs.”

Lanton Law is a national boutique law and government affairs firm that focuses on healthcare/life sciences, technology and finance. 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.

Ron Lanton 7/27/20 Ron Lanton 7/27/20

White House Issues Executive Order Advocating for Importation

The White House has issued an Executive Order titled “Executive Order on Increasing Drug Importation to Lower Prices for American Patients,” which seeks to advocate for having supply chain entities proceed with importation.

“One way to minimize international disparities in price is to increase the trade of prescription drugs between nations with lower prices and those with persistently higher ones. Over time, reducing trade barriers and increasing the exchange of drugs will likely result in lower prices for the country that is paying more for drugs. For example, in the European Union, a market characterized by price controls and significant barriers to entry, the parallel trade of drugs has existed for decades and has been estimated to reduce the price of certain drugs by up to 20 percent. Accordingly, my Administration supports the goal of safe importation of prescription drugs.”

The Executive Order gives stakeholders three methods to accomplish the goals of this order. Either allow reimportation of insulin products from Canada, finalize the December 2019 proposed rule addressing importation, or allow individuals to import drugs as long as the importation is designated by the Food & Drug Administration (FDA) as safe and results in lower costs to patients.

(a) facilitating grants to individuals of waivers of the prohibition of importation of prescription drugs, provided such importation poses no additional risk to public safety and results in lower costs to American patients, pursuant to section 804(j)(2) of the Federal Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C. 384(j)(2);
(b) authorizing the re-importation of insulin products upon a finding by the Secretary that it is required for emergency medical care pursuant to section 801(d) of the FDCA, 21 U.S.C. 381(d); and
(c) completing the rulemaking process regarding the proposed rule to implement section 804(b) through (h) of the FDCA, 21 U.S.C. 384(b) through (h), to allow importation of certain prescription drugs from Canada.

Ron Lanton 7/27/20 Ron Lanton 7/27/20

The Administration Releases Executive Order Targeting Insulin and Injectable Epinephrine via 340B

The White House has announced a few Executive Orders targeting healthcare. One Executive Order titled Executive Order on Access to Affordable Life-saving Medications targets insulin and injectable epinephrine by requiring federally qualified community health centers to pass through 340B program discounts to patients using insulin and epinephrine auto-injectors.

Specifically the Executive Order outlines the following:

“It is the policy of the United States to enable Americans without access to affordable insulin and injectable epinephrine through commercial insurance or Federal programs, such as Medicare and Medicaid, to purchase these pharmaceuticals from an FQHC at a price that aligns with the cost at which the FQHC acquired the medication.

To the extent permitted by law, the Secretary of Health and Human Services shall take action to ensure future grants available under section 330(e) of the Public Health Service Act, as amended, 42 U.S.C. 254b(e), are conditioned upon FQHCs’ having established practices to make insulin and injectable epinephrine available at the discounted price paid by the FQHC grantee or sub-grantee under the 340B Prescription Drug Program (plus a minimal administration fee) to individuals with low incomes, as determined by the Secretary, who:

(a) have a high cost sharing requirement for either insulin or injectable epinephrine;

(b) have a high unmet deductible; or

(c) have no health care insurance.”

This will be interesting to see how this gets enforced. The 340B program which is where manufacturers provide outpatient drugs to eligible healthcare entities at a reduced price has been embroiled in controversy the last several years between manufacturers and hospitals over pricing. This Order does not address hospital practices.