Ron Lanton 8/10/21 Ron Lanton 8/10/21

FDA Approves First Interchangeable Biosimilar

The U.S. Food and Drug Administration (FDA) has “approved the first interchangeable biosimilar insulin product, indicated to improve glycemic control in adults and pediatric patients with Type 1 diabetes mellitus and in adults with Type 2 diabetes mellitus. Semglee (insulin glargine-yfgn) is both biosimilar to, and interchangeable with (can be substituted for), its reference product Lantus (insulin glargine), a long-acting insulin analog. Semglee (insulin glargine-yfgn) is the first interchangeable biosimilar product approved in the U.S. for the treatment of diabetes. Approval of these insulin products can provide patients with additional safe, high-quality and potentially cost-effective options for treating diabetes.

Biological products include medications for treating many serious illnesses and chronic health conditions, including diabetes. A biosimilar is a biological product that is highly similar to, and has no clinically meaningful differences from, a biological product already approved by the FDA (also called the reference product). This means you can expect the same safety and effectiveness from the biosimilar as you would the reference product.

An interchangeable biosimilar product may be substituted for the reference product without the intervention of the prescriber. The substitution may occur at the pharmacy, a practice commonly called “pharmacy-level substitution”—much like how generic drugs are substituted for brand name drugs, subject to state pharmacy laws, which vary by state. Biosimilar and interchangeable biosimilar products have the potential to reduce health care costs, similar to how generic drugs have reduced costs. Biosimilars marketed in the U.S. typically have launched with initial list prices 15% to 35% lower than comparative list prices of the reference products.”

Lanton Law is a national boutique law and lobbying firm that focuses on healthcare/life sciences 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 8/10/21 Ron Lanton 8/10/21

CMS Proposes Rescinding Most Favored Nation Interim Final Rule

The Centers for Medicare and Medicaid Services (CMS) has released a proposed rule that seeks to rescind the Most Favored Nation Model interim final rule with comment period that appeared in the November 27, 2020 Federal Register. CMS is seeking public comment by October 12, 2021.

This rule has already had some interesting history. According to the proposal, “In December 2020, while the comment period was open, four lawsuits were filed related to CMS's waivers of proposed rulemaking and delay in effective date as well as other aspects of the MFN Model and the November 2020 interim final rule.

On January 8, 2021, the Solicitor General determined not to appeal the preliminary injunction issued in California Life Sciences. On January 19, 2021, at the parties' request, the U.S. Northern District of California stayed the case until at least April 23, 2021. Subsequently, on April 26, 2021, another stay was granted until July 26, 2021. On July 29, 2021, another stay was granted until September 27, 2021.

In Regeneron Pharmaceuticals, on February 2, 2021, the plaintiff filed a letter seeking leave to file a motion for summary judgment, and HHS filed a letter seeking leave to file a motion for a stay. On February 10, 2021, the U.S. District Court for the Southern District of New York granted HHS's request and stayed the case for 90 days (that is, through May 11, 2021). On May 10, 2021, the stay in this case was extended for an additional 90 days, until August 9, 2021, to give HHS time to consider how to proceed with the rule in light of the “unanimous” court decisions to date. In its order, the court noted that HHS should “not assume that another stay will be granted,” as the stays gave HHS “a half-year to reach a conclusion regarding how to proceed[.]”

As a result of the nationwide preliminary injunction, the MFN Model was not implemented on January 1, 2021, as contemplated in the November 2020 interim final rule. While the nationwide preliminary injunction has been in place, CMS considered how to proceed given stakeholders' concerns about potential impacts of the MFN Model.”

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

Ron Lanton 7/12/21 Ron Lanton 7/12/21

President Biden Issues Executive Order Aimed at Multiple Industries

President Biden has issued an Executive Order (EO) titled Executive Order on Promoting Competition in the American Economy.

President Biden has issued an Executive Order (EO) titled Executive Order on Promoting Competition in the American Economy. The EO advocates for promoting “competition in the American economy, which will lower prices for families, increase wages for workers, and promote innovation and even faster economic growth.” In doing so multiple sectors of the economy including labor, healthcare, transportation, agriculture, communications, technology, banking and finance have been targeted.

As our economy emerges from the pandemic, we foresee that state and federal policymakers will be taking a look to see what laws need to be strengthened or reworked for our reimagined economy.

Lanton Law is a national boutique law and lobbying firm that focuses on highly regulated industries such as healthcare, 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 6/17/21 Ron Lanton 6/17/21

Protecting Rural Telehealth Access Act Introduced

Via a recently released a press release describing how a group of bipartisan Senators including Joe Manchin (D-WV), Joni Ernst (R-IA), Jeanne Shaheen (D-NH), and Jerry Moran (R-KS) have introduced the bipartisan Protecting Rural Telehealth Access Act to make current telehealth flexibilities permanent.

“This legislation would ensure rural and underserved community healthcare providers are able to continue offering telehealth services after the current public health emergency ends. These services include the ability to offer audio-only telehealth appointments because many rural Americans don’t have reliable, affordable broadband access.”

According to the press release the proposed Act would:

Allow payment-parity for audio-only health services for clinically appropriate appointments. During COVID-19, recognizing not everyone has access to the technology in their home, Congress made allowances for audio-only telephone services to be used to allow doctors to reach patients wherever they are.
Permanently waive the geographic restriction allowing patients to be treated from their homes. Pre-COVID-19, the home was allowed as an eligible originating site in Medicare and some Medicaid programs, but only for very specific services, and only for the patient, not the provider.
Permanently allow rural health clinics and Federally Qualified Health Centers to serve as distance sites for providing telehealth services.
Lift the restrictions on “store and forward” technologies for telehealth. Currently this is only allowed in Hawaii and Alaska.
Allows Critical Access Hospitals (CAHs) to directly bill for telehealth services.

Lanton Law is a national boutique law and lobbying firm that focuses on healthcare/life science and technology. Our telepharmacy practice has been helping pharmacies and physicians with operational issues, mergers and acquisitions, regulatory inquiries, audits, licensure, employment issues and contracting.

Ron Lanton 6/17/21 Ron Lanton 6/17/21

Data Protection Agency (DPA) Legislation Reintroduced

U.S. Senator Gillibrand (D-NY) issued a press release announcing the Data Protection Act of 2021, which would create the DPA, an independent federal agency whose goal is to protect Americans’ data, instill privacy safeguards and work to ensure that there is transparency in data sharing practices.

There have been some changes to this proposed legislation since last year’s version of the bill. These changes include:

Supervision of Data Aggregators: Grants the DPA authority to review Big Tech mergers involving a large data aggregator, or any merger that proposes the transfer of personal data of 50,000 or more individuals.
Office of Civil Rights: Establishes the DPA Office of Civil Rights to advance data justice and protect individuals from discrimination.
Enforcement Powers: Improves DPA enforcement powers to oversee the use of high-risk data practices and to penalize, examine, and propose remedies to the social, ethical, and economic impacts of data collection.
Penalties and Fines: Prohibits data aggregators from committing any unlawful, unfair, deceptive, abusive, or discriminatory data practices; and allows for penalties and fines to be levied if violated, including triple penalties for violations against children.
Defines Key Terms for Transparency: Provides Key Definitions for Privacy Harm, Data Aggregators, and High-Risk Data Practice, among other key terms.

According to the release “The DPA would be an executive agency. The director would be appointed by the president and confirmed by the Senate, serves a 5-year term, and must have knowledge of technology, protection of personal data, civil rights, and law. The agency may investigate, subpoena for testimony or documents, and issue civil investigative demands. It may prescribe rules and issue orders and guidance as is necessary to carry out federal privacy laws. The authority of state agencies and state attorneys general are preserved in the Act. The DPA would have three core missions:

1. Give Americans control and protection over their own data by authorizing the DPA to create and enforce data protection rules.

2. Maintain the most innovative, successful tech sector in the world by ensuring fair competition within the digital marketplace.

3. Prepare the American government for the digital age.”

Lanton Law’s technology practice has been monitoring privacy developments nationwide. If you are a banking/finance, technology or healthcare/life science 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 6/17/21 Ron Lanton 6/17/21

House Lawmakers Release Anti-Monopoly Agenda for “A Stronger Online Economy: Opportunity, Innovation, Choice”

According to press release, the House Committee on the Judiciary’s Antitrust Subcommittee Chairman Cicilline (D-RI) and Ranking Member Buck (R-CO) announced their antitrust bi-partisan agenda outlined below:

“‘A Stronger Online Economy: Opportunity, Innovation, Choice’ consists of five bipartisan bills drafted by lawmakers on the Antitrust Subcommittee, which last year completed a 16-month investigation into the state of competition in the digital marketplace and the unregulated power wielded by Amazon, Apple, Facebook, and Google.”

The “American Innovation and Choice Online Act” to prohibit discriminatory conduct by dominant platforms, including a ban on self-preferencing and picking winners and losers online. The bill is sponsored by Chairman Cicilline and co-sponsored by U.S. Rep. Lance Gooden (TX-05).

The “Platform Competition and Opportunity Act” prohibits acquisitions of competitive threats by dominant platforms, as well as acquisitions that expand or entrench the market power of online platforms. The bill is sponsored by U.S. Rep. Hakeem Jeffries (NY-08) and co-sponsored by Ranking Member Buck.

The “Ending Platform Monopolies Act” eliminates the ability of dominant platforms to leverage their control over multiple business lines to self-preference and disadvantage competitors in ways that undermine free and fair competition. The bill is sponsored by U.S. Rep. Pramila Jayapal (WA-07) and co-sponsored by U.S. Rep. Lance Gooden (TX-05).

The “Augmenting Compatibility and Competition by Enabling Service Switching (ACCESS) Act” promotes competition online by lowering barriers to entry and switching costs for businesses and consumers through interoperability and data portability requirements. This bill is sponsored by U.S. Rep. Mary Gay Scanlon (PA-05) and co-sponsored by U.S. Rep. Burgess Owens (UT-04).

The “Merger Filing Fee Modernization Act” updates filing fees for mergers for the first time in two decades to ensure that the Department of Justice and Federal Trade Commission have the resources they need to aggressively enforce the antitrust laws. This bill is sponsored by U.S. Rep. Joe Neguse (CO-02) and co-sponsored by U.S. Rep. Victoria Spartz (IN-05).

Lanton Law has been monitoring both Congress and the FTC for our technology and healthcare clients, especially as both Congress and the FTC have taken a more aggressive tone on antitrust issues lately.

Lanton Law is a national boutique regulatory 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 6/17/21 Ron Lanton 6/17/21

Lina Khan Sworn in as FTC Chair

The Federal Trade Commission (FTC) released a June 15th press release announcing Lina Khan as the Chair of the FTC, with her term expiring on September 25, 2024. Ms. Khan was confirmed by the U.S. Senate on June 15, 2021.

Lanton Law has been monitoring the FTC for our technology and healthcare clients. This move may signal that the Biden Administration and Congress may take on a more aggressive role in antitrust policy. Technology stakeholders should take note.

Ron Lanton 6/17/21 Ron Lanton 6/17/21

New Proposed Congressional DIR Relief Bill

At Lanton Law we are constantly on the watch for issues impacting our specialty, retail and LTC pharmacy clients including the issue of DIR fees. Clients utilize our advocacy and legal tools while discussing business strategy to combat an ever changing reimbursement environment.

A bipartisan group of Congressional legislators have introduced the Pharmacy DIR Reform to Reduce Senior Drug Costs Act, also known as S. 1909/H.R. 3554. Both companion bills propose to transfer all pharmacy DIR to the point of sale. As many in the industry know, DIR fees were intended to be applied here but the definition and application of DIR fees have been so convoluted that they are causing deep and long lasting damage to the pharmacy community.

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 section helps pharmacies nationwide achieve improved business climates through carefully crafted legislation.

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

Bipartisan Congressional Legislation Introduced Seeking Shared Savings Demo Project to Increase Biological/Biosimilar Medicare Access

U.S. Senators Cornyn (R-TX) and Bennet (D-CO) have introduced the Increasing Access to Biosimilars Act also known as S. 1427. The bill seeks to establish a demonstration project to increase access to biosimilar biological products under the Medicare program.

According to Senator Cornyn’s press release “this legislation would direct HHS to establish a shared savings demonstration project to increase access to biosimilars in the Medicare program. This would encourage physicians to prescribe less-expensive biosimilars increasing patient access to more affordable, life-saving drugs and lowering patient out-of-pocket costs.

Under the demonstration, Medicare would provide an additional payment to providers for using lower-cost biosimilar products that reflects the savings created in contrast to administering the higher-cost reference biological product. Additionally, Medicare can use a portion of those savings to reduce the beneficiary’s coinsurance payment.”

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 6/2/21 Ron Lanton 6/2/21

Biden Administration Files Motion Supporting Canadian Drug Imports

The Biden Administration has filed a motion in federal district court for the District of Columbia. The motion seeks to dismiss a lawsuit that aims to prevent prescription drug imports from Canada.

The Biden Administration has filed a motion in federal district court for the District of Columbia. The motion seeks to dismiss a lawsuit that aims to prevent prescription drug imports from Canada. This motion is aimed at prior enacted state legislation from both Florida and New Mexico, as both states have commenced the process of applying for Canadian imports. The Administration argues in its brief that the party opponent’s (Pharmaceutical Research & Manufacturers of America PhRMA) claim is not prudentially ripe.

Importation is an issue that Lanton Law has been monitoring for several years. As the drug pricing debate continues across Congress and state legislatures, we fully anticipate importation to continue to be a front and center policy issue.

Ron Lanton 5/14/21 Ron Lanton 5/14/21

New Executive Order on Cybersecurity Released in Response to Ransomware Attack

In the wake of the Colonial Pipeline attack, President Biden has signed the Executive Order on Improving the Nation's Cybersecurity.

In the wake of the Colonial Pipeline attack, President Biden has signed the Executive Order on Improving the Nation's Cybersecurity. The EO has a number of provisions including:

Establishes a “Cybersecurity Safety Review Board” comprising public- and private-sector officials, which can convene after cyber attacks to analyze the situation and make recommendations.
Requires IT service providers to tell the government about cybersecurity breaches that could impact U.S. networks, and removes certain contractual barriers that might stop providers from flagging breaches.
Plans for enhancing software supply chain security

This comes amid an increase in cyber attacks on private healthcare and technology companies as well as the federal government.

Ransomware attacks are becoming a bigger threat and being prepared from a compliance and risk management standpoint is becoming more crucial. Having appropriate cyber policies in place is one step. We have other solutions.

Lanton Law is a national boutique law and lobbying firm that focuses on technology and healthcare. 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 4/12/21 Ron Lanton 4/12/21

Cybersecurity & FY 22 Discretionary Funding Request

The President’s request for fiscal year 2022 discretionary funding has been released. Below are a few mentions for cybersecurity:

To support agencies as they modernize, strengthen, and secure antiquated information systems and bolster Federal cybersecurity the discretionary equest recommends $500 million for the Technology Modernization Fund, an additional $110 million for the Cybersecurity and Infrastructure Security Agency, and $750 million as a reserve for Federal agency information technology enhancements.

With increased hacking and ransomware attacks, cybersecurity is going to be more front and center for both policy and legal discussions. For example in this request by the Administration, the attack on SolarWinds Corp. and Microsoft Exchange’s email servers were expressly mentioned. For stakeholders that traffic in data, cybersecurity policies are essential. Ensuring compliance with federal and state requirements are key and we can help.

Ron Lanton 3/15/21 Ron Lanton 3/15/21

Biosimilar Legislation Passes Senate

S. 164 titled the Advancing Education on Biosimilars Act of 2021 sponsored by Senator Hassan (D-NH) has passed the Senate on March 3, 2021. The proposed bill seeks to educate health care providers and the public on biosimilar biological products.

Specifically, the bill states that the Secretary may maintain and operate an internet website to provide educational materials for health care providers, patients, and caregivers, regarding the meaning of the terms, and the standards for review and licensing of, biological products, including biosimilar biological products and interchangeable biosimilar biological products.

Ron Lanton 3/9/21 Ron Lanton 3/9/21

New Psychedelic ETF About To Hit the Market

There is a new March 5, 2021 U.S. Securities Exchange Commission (SEC) filing that will allow investors to gain exposure to the psychedelic and cannabis industries.

There is a new March 5, 2021 U.S. Securities Exchange Commission (SEC) filing that will allow investors to gain exposure to the psychedelic and cannabis industries. According to the fling, the Defiance Next Gen Altered Experience ETF is:

The Index is a rules-based index that tracks the performance of a portfolio of life sciences companies conducting federally legal medical activities in the psychedelics, medical cannabis, hemp, and cannabidiol (“CBD”) industries whose common stock or depositary receipts are listed on a U.S. or Canadian exchange. Psychedelic drugs, also known as hallucinogens, are a group of substances, including psilocybin, that are used to change and enhance sensory perceptions, thought processes, and energy levels. Medical cannabis, also known as medical marijuana, refers to the use of parts of the marijuana plant, such as hemp and the plant’s chemicals, for the treatment of a variety of diseases or medical conditions. Hemp is a type of cannabis plant whose stalks and seeds are used for a variety of commercial products.

While Lanton Law is not making any statements about whether people should invest in this or not, we are simply monitoring the industry to let interested stakeholders know about the developments within the cannabis market.

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.

Ron Lanton 2/17/21 Ron Lanton 2/17/21

New York Privacy Act Introduced into the New York State Legislature

A680 titled the New York Privacy Act has been introduced into the New York State Assembly. The bill is sponsored by Assemblywoman Rosenthal (D-District 67).

The proposed bill seeks to enact the NY privacy act to require companies to disclose their methods of de-identifying personal information, to place special safeguards around data sharing and to allow consumers to obtain the names of all entities with whom their information is shared. Furthermore the proposed bill creates a special account to fund a new office of privacy and data protection.

While the bill has echoes of Europe’s General Data Protection Regulation consent requirements, this bill takes a hard line approach on the subject which requires consent for all processing activities and third-party disclosures, with no exceptions, the proposed bill as currently written raises significant concerns with how businesses would realistically be able to comply with the proposal’s requirements.

Penalties are very strong under this proposal as seen below:

The attorney general may bring an action in the name of the state,or as parens patriae on behalf of persons residing in the state, to enforce this article.

In addition to any right of action granted to any governmental body pursuant to this section, any person who has been injured by reason of a violation of this article may bring an action in his or her own name to enjoin such unlawful act, or to recover his or her actual damages, or both such actions. The court may award reasonable attorney's fees to a prevailing plaintiff.

Any controller or processor who violates this article is subject to an injunction and liable for damages and a civil penalty. When calculating damages and civil penalties, the court shall consider the number of affected individuals, the severity of the violation, and the size and revenues of the covered entity. Each individual whose information was unlawfully processed counts as a separate violation. Each provision of this article that was violated counts as a separate violation.

Privacy is a hotly trending topic that is showing now signs of slowing down. Bills like this one will require significant work as it makes its way through the legislature in order for New York to achieve consumer protection while enacting a workable law that businesses will be able to comply with.

We at Lanton Law can help. Our legal and lobbying tools can help offer your organization a clear path forward to navigate what will be changing policies for healthcare, technology and clean energy stakeholders. We are a D.C. based firm with no state boundaries as we are active nationwide. Contact us today to discuss your options.

Ron Lanton 2/16/21 Ron Lanton 2/16/21

Virginia on Track to Become Second Second State to Pass Data Privacy Laws

Lanton Law’s privacy practice has been closely monitoring the various state conversations around data privacy. We previously wrote a blog post titled California’s Consumer Privacy Act Could Be Coming to a State Near You, where we traced how California took the first step to create a consumer privacy law in the wake of Europe’s General Data Protection Regulation.

So what’s going on with Virginia? Earlier this month the Virginia Senate passed

Senate Bill 1392, titled the Consumer Data Protection Act. The Virginia House of Delegates approved a companion (identical) House Bill H.B. 2307 by an 89-9 vote. Each bill likely will be heard in committee next week by the opposite chamber, which provides additional opportunities to make amendments. The state General Assembly will adjourn on March 1, it is expected that Governor Northam will sign the legislation.

What does the bill do? The proposed legislation seeks the following:

“Establishes a framework for controlling and processing personal data in the Commonwealth. The bill applies to all persons that conduct business in the Commonwealth and either (i) control or process personal data of at least 100,000 consumers or (ii) derive over 50 percent of gross revenue from the sale of personal data and control or process personal data of at least 25,000 consumers. The bill outlines responsibilities and privacy protection standards for data controllers and processors. The bill does not apply to state or local governmental entities and contains exceptions for certain types of data and information governed by federal law. The bill grants consumer rights to access, correct, delete, obtain a copy of personal data, and to opt out of the processing of personal data for the purposes of targeted advertising. The bill provides that the Attorney General has exclusive authority to enforce violations of the law, and the Consumer Privacy Fund is created to support this effort. The bill has a delayed effective date of January 1, 2023.”

As with major policy issues that have yet to have a federal solution, states like California, Virginia and others are creating piecemeal policies, which will create compliance issues for entities that operate in several jurisdictions. New York, Oklahoma, Washington State, Minnesota, and North Dakota are jurisdictions that we continue to monitor with brewing policies on point.

As we become more reliant on technology which crosses several sectors now, businesses are finding that they have to increase their awareness of state and federal policy in order to remain compliant. We at Lanton Law can help. Our legal and lobbying tools can help offer your organization a clear path forward to navigate what will be changing policies for healthcare, technology and clean energy stakeholders. We are a D.C. based firm with no state boundaries as we are active nationwide. Contact us today to discuss your options.

Ron Lanton 2/7/21 Ron Lanton 2/7/21

Senator Klobuchar Introduces Sweeping Omnibus Antitrust Reform Legislation

U.S. Senator Amy Klobuchar (D-MN), the lead Democrat on the Judiciary Subcommittee on Antitrust, Competition Policy and Consumer Rights, recently introduced sweeping proposed legislation targeting antitrust reform.

According to her office’s release, the Competition and Antitrust Law Enforcement Reform Act will strengthen regulator oversight tools, reform enforcement and strengthen prohibitions on anticompetitive mergers and conduct.

Specifically the bill seeks to accomplish the following:

Increase enforcement resources
Strengthen prohibitions against anti competitive mergers
Prevent harmful dominant firm conduct
Establishes a new, independent FTC division to conduct market studies and merger retrospectives
Implement additional reforms to enhance antitrust enforcement

Interestingly, the The bill also clarifies that the law applies not only to monopoly power, but also to monopsony power, a company's power as a buyer or employer in the market.

There have been several mergers and acquisitions over the years that have raised questions about the long term effects of specific sectors, but the fears of a more aggressive regulator has not been of concern until now.

Lanton Law is a national boutique law and lobbying firm that focuses on healthcare/life sciences, technology and clean energy. Contact us today to learn about your organization’s options to prepare for additional regulatory antitrust oversight.

Ron Lanton 2/3/21 Ron Lanton 2/3/21

Jazz Pharmaceuticals Purchases GW Pharmaceuticals for $7.2 billion

Jazz Pharmaceuticals has announced that it will “acquire GW for $220.00 per American Depositary Share (ADS), in the form of $200.00 in cash and $20.00 in Jazz ordinary shares, for a total consideration of $7.2 billion, or $6.7 billion net of GW cash. The transaction, which has been unanimously approved by the Boards of Directors of both companies, is expected to close in the second quarter of 2021.”

“GW is a global leader in discovering, developing, manufacturing and commercializing novel, regulatory approved therapeutics from its proprietary cannabinoid product platform to address a broad range of diseases. The company's lead product, Epidiolex® (cannabidiol) oral solution, is approved in patients one-year and older for the treatment of seizures associated with Lennox-Gastaut Syndrome (LGS), Dravet Syndrome and Tuberous Sclerosis Complex (TSC), all of which are rare diseases characterized by severe early-onset epilepsy. Epidiolex was the first plant-derived cannabinoid medicine ever approved by the U.S. Food and Drug Administration (FDA).”

Interestingly, Epidiolex brought in approximately $510 million in annual sales within two years of its launch.

The cannabis market is definitely an emerging one with high growth potential for interested stakeholders. We foresee that there will be additional deals in the near term as more companies embrace this sector. However; the cannabis industry has several federal and state regulatory hurdles to overcome.

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.

Ron Lanton 1/28/21 Ron Lanton 1/28/21

Lanton Strategies: D.C. Based Lobbying Firm with No State Boundaries

COVID-19 has changed the way that we interact in a variety of ways. One of them being the way that businesses large and small interact with the government. Gone are the days where we can meet people in person without having to worry about travel restrictions and COVID-19 protocol. What remains is that businesses still need to get their voices heard. This is where Lanton Strategies has a strategic advantage.

For years our firm has made connections nationwide that have allowed us to tap our business and industry rolodex in order to get client goals realized. Our unique holistic approach enables us to lobby legislators and regulators, no matter the state. In essence we are that “digital lobbyist firm” that you need.

If you are looking for federal or state solutions and you’re unsure how to get something done, contact Lanton Strategies; a division of Lanton Law

Ron Lanton 1/11/21 Ron Lanton 1/11/21

Biometric Policies Will Likely Be Debated Nationwide in 2021

New York has introduced Assembly Bill 27. According to the proposed bill, AB 27 seeks “to establish the biometric privacy act;

New York has introduced Assembly Bill 27. According to the proposed bill, AB 27 seeks “to establish the biometric privacy act; requires private entities in possession of biometric identifiers or biometric information to develop a written policy establishing a retention schedule and guidelines for permanently destroying biometric identifiers and biometric information when the initial purpose for collecting or obtaining such identifiers or information has been satisfied or within three years of the individual's last interaction with the private entity, whichever occurs first.”

Currently, the Illinois Biometric Information Privacy Act, commonly known as BIPA, is the only state with a biometric privacy statute that provides for a similar private right of action. We have been writing in previous posts about how state policies have been taking shape regarding this subject.

We expect this and other technology questions to be debated in various state houses throughout 2021. It is imperative for interested stakeholders to be prepared for what new potential legislation requires. Contact Lanton Law to discuss your lobbying and legal strategies.