Attorney East Hampton

The American Conference Institute’s (“ACI’s”) popular “FDA Boot Camp” – now in its 36th iteration – is scheduled to take place from March 24-25, 2021 (Eastern Time).  The conference is billed as the premier event to provide folks with a roadmap to navigate the difficult terrain of FDA regulatory law.  And like a lot of conferences over the past year, the ACI conference format has changed from a live, in-person event to an interactive, virtual conference.

ACI’s FDA Boot Camp will provide you not only with the essential background in FDA regulatory law to help you in your practice, but also key sessions that show you how this regulatory knowledge can be applied to situations you encounter in real life. A distinguished cast of presenters will share their knowledge and provide critical insights on a host of topics, including:

• The organization, jurisdiction, functions, and operations of FDA
• The essentials of the approval process for drugs and biologics
• Clinical trials for drugs and biologics
• The role of the Hatch-Waxman Act in the patenting of drugs and biologics
• Labeling in the drug and biologics approval process
• cGMPs and other manufacturing concerns relative to products liability
• Proactive adverse events monitoring and signal detection
• Recalls, product withdrawals, and FDA oversight authority

Hyman, Phelps & McNamara, P.C.’s Kurt R. Karst is co-chairing the conference and will also present at a session titled “Understanding the Relevance of New FDA Initiatives and Policies and How They May Redefine the Life Sciences Industry in the Aftermath of COVID-19.”

FDA Law Blog is a conference media partner. As such, we can offer our readers a special 10% discount. The discount code is: D10-874-874EX05.  You can access the conference brochure and sign up for the event here.  We look forward to seeing you (virtually, of course) at the conference.

By Karin F.R. Moore & Ricardo Carvajal & Riëtte van Laack —

Welcome to the latest edition of HPM’s monthly wrap up of food, beverage and supplement news, including regulations, guidances, events, and whatever else is catching our eye. It’s been quite a January, hasn’t it?

Food & Beverage

• Transition: As of this writing, Janet Woodcock is Acting Commissioner of Food and Drugs; Norris Cochran is Acting Secretary of Health & Human Services; and Kevin Shea is Acting Secretary of Agriculture.
• Whither regulation of bioengineered animals? USDA and HHS officials signed an MOU under which USDA would take the lead on regulation of bioengineered animals intended for agricultural purposes. Then-Commissioner Hahn quickly disavowed the MOU via Twitter, thereby suggesting that the future of that initiative is uncertain.
• Another source of protein. EFSA has declared mealworms safe for human consumption. This is their first opinion on insects as a novel food and could help drive the category forward.
• Uniformity is good. The FDA announced that January 1, 2024, will be the uniform compliance date for final food labeling regulations that are issued in calendar years 2021 and 2022. This action does not change existing requirements for compliance dates contained in final rules published before January 1, 2021.
• Traceability is good too. The FDA published FAQs about the FSMA Food Traceability Proposed Rule to assist those considering submitting comments (due Feb. 21, 2021). FDA also updated its Food Traceability List to provide some clarity (without changing any of the listed foods).
• Not-so Short Form. On January 8, 2021, California’s Office of Environmental Health Hazard Assessment (OEHHA) announcedproposed amendments to Proposition 65 warning regulations that would limit use of the short-form version of the safe harbor warning. Check out Riëtte’s blog post for more information.

Supplements

• Another try at CBD: Legislation was again introduced in Congress that would make lawful the use of hemp and its derivatives (including CBD) as dietary ingredients in a dietary supplement, provided that the supplement complies with all other applicable requirements. Hat tip to CRN, which posted the bill on its website.
• And another NAD decision on “natural”: NAD took issue with the word “natural” in a brand name used for products in which the key ingredients are not naturally derived. Other aspects of the decision also make it a worthwhile read.

More on Cannabis

• Just under the wire: As the Trump administration was winding down, the USDA finalized on Jan. 15 its regulatory framework for the Establishment of a Domestic Hemp Production Program, which takes effect on March 22.
• Out with the old: The Biden administration sent a memo to all federal agencies on January 20 telling them to withdraw pending rules, and the Cannabidiol Enforcement Policy; Draft Guidance for Industry was

Other things that caught our eye:

• AMG v. FTC: With a legal question that led to a classic oral argument where all nine Justices refused to tip their hands on how the case will turn out, the U.S. Supreme Court this month heard oral argumentsin AMG Capital Management v. Federal Trade Commission. Karin’s blog post has more details.

 

The American Conference Institute (“ACI”) is sponsoring its Advanced Legal, Regulatory, and Compliance Forum on OTC Drugs Conference on February 26, 2021 (Eastern Time).  Like a lot of conferences over the past year, the ACI conference format has changed from a live, in-person event to an interactive, virtual conference.

Hear from leading OTC industry counsel and regulatory executives who will provide timely analysis and best practices for:

• Preparing for monograph reform under the CARES Act
• Substantiating COVID-related claims
• Identifying labeling and manufacturing missteps for imports, to avoid costly hold ups at the border
• Leveraging lessons from recent Rx-to-OTC switch success stories to overcome complex legal and regulatory hurdles
• Navigating recalls and adverse events protocols

Hyman, Phelps & McNamara, P.C.’s Deborah L. Livornese will be speaking at a session titled “How to Prepare for a Modernized OTC Drug System under the CARES Act.”

FDA Law Blog is a conference media partner. As such, we can offer our readers a special 10% discount. The discount code is: D10-826-826DX01. You can access the conference brochure and sign up for the event here.  We look forward to “seeing you at the conference.”

By Alan M. Kirschenbaum —

In late November, the OIG published a final rule that excludes from the Federal healthcare program safe harbor for discounts rebates paid to Medicare Part D plans, or their PBMs (see our post here).  The rule also establishes two new safe harbors: one for rebates paid to Medicare Part D plans and Medicaid Managed Care plans, or their PBMs, if the rebates are passed through by the plan or PBM to the dispensing pharmacy; and another for service fees paid to PBMs.  Together, these safe harbor amendments were intended to force PBMs to pass manufacturer rebates through to pharmacies to lower the out‑of‑pocket costs of government beneficiaries at the pharmacy counter.  The exclusion from the discount safe harbor had a delayed effective date of January 1, 2022, while the two new safe harbors were scheduled to go into effect on January 29, 2021 (last Friday).  However, since Friday, both the discount safe harbor exclusion and the new safe harbors have now been delayed further.

On Friday, just under its deadline, the OIG issued a “correction” to the two new safe harbors delaying their effective dates until March 22, 2021.  The delay was pursuant to the regulatory freeze issued by the White House on inauguration day, which, among other things, directed federal agencies to consider delaying published rules that have not yet become effective for 60 days, and longer where necessary, to permit the agency and OMB to review factual, legal, and policy issues raised by the rule.

On Saturday — the very next day — the new discount safe harbor exclusion was also delayed, this time by court order.  Earlier this month, before the change in administration, the Pharmaceutical Care Management Association (PCMA), a trade association of PBMs, had sued HHS to vacate the rule on procedural and substantive grounds.  Saturday’s Order delayed the effective date of the exclusion one year from January 1, 2022 to January 1, 2023, “pending the duration of HHS’ review of the November 20, 2020 rule,” with the consent of the parties.

The fate of these safe harbor amendments under the Biden administration is in doubt.  As we pointed out in our previous post, the safe harbor amendments would reduce coinsurance for some federal program enrollees but would preclude PBMs from using rebates to reduce premiums across all enrollees.  The Congressional Budget Office estimated that the impact would be to increase Medicare and Medicaid spending by $177 billion over 10 years.  This Administration, like the previous one, has committed to reducing drug prices, but can be expected to favor price reduction measures that do not increase costs to the government.

By Douglas B. Farquhar —

At a conference sponsored by the Parenteral Drug Association on January 27, speakers demonstrated that:

• Industry has developed best practices for auditors or regulatory inspectors to conduct virtual inspections of drug-manufacturing facilities (virtual inspections are those in which the auditor or inspector is not physically on-site, but, instead, conducts the inspection remotely through audio or video streaming techniques, or both).
• Advanced technology is available and is easily controlled by remote auditors in such a fashion as to replicate the physical presence on-site of an inspector or even a team of inspectors.
• Sponsors of approved applications for drugs regularly conduct virtual audits of their Contract Manufacturing Organizations (CMOs).
• Other drug-manufacturing regulatory agencies worldwide routinely conduct virtual inspections, and have done so since COVID-19 began to shut down travel of inspectors.

As we have previously reported (here, here, and here) and as my colleague Mark Schwartz wrote in a Bloomberg article, numerous FDA approvals of critically needed drugs are being blocked because FDA is insisting that the approvals must await in-person inspection of the facilities manufacturing either drugs or the Active Pharmaceutical Ingredients that are essential components of pharmaceuticals.  And yet FDA has not promulgated guidance or publicized policies on virtual FDA inspections so that the unnecessary blockade of drug approvals can be lifted.  FDA has claimed it has performed virtual inspections of food-manufacturing facilities, but has not claimed that it has performed a single virtual inspection of a drug-manufacturing facility.  By contrast, the European drug manufacturing regulatory body (the European Medicines Agency, or EMA) and its British counterpart (the Medicines and Healthcare products Regulatory Agency, or MHRA) have been performing such inspections since March.

At the PDA webinar, which was attended by more than 350 individuals involved in drug manufacturing (and also apparently by some FDA officials: let’s hope they recognize the ease and promise of virtual inspections), presentations described the procedures that drug manufacturers should establish for the conduct of virtual inspections (including that video and audio should be streamed in real time, without alteration or enhancement) and discussed the practices that inspected entities need to embrace (such as ensuring that adequate wifi capabilities are available in all areas which are subject to inspection).  (This blogpost will be updated to provide a link to the presentations, when they are available.)  One presenter, Peter Miller of Dynamic Compliance Solutions, demonstrated a 360camera that provides viewers of the video feed the same capabilities that an inspector or multiple inspectors would have if they were personally present at the inspected facility.  As you can see in the brief video, viewers can:

• Instruct personnel on-site to move the camera to particular places or in certain directions;
• Remotely pan or tilt the view provided by the camera as the remote inspectors wish, and, if there are multiple remote inspectors, each viewer can tilt or pan the camera to view different areas, people, or equipment as they wish (by left-clicking and rolling the mouse), and can zoom in and out;
• Interview plant personnel; and
• Demand to view specific documents through a flexible and high-resolution document camera.

Which brings us to the immortal lyrics of Cole Porter, popularized by Ella Fitzgerald.  “Let’s Fall in Love” suggested that “birds do it, bees do it, even educated fleas do it,” and implied, “Why don’t we do it?”  The same question could be asked of FDA about virtual inspections.  (This blogger’s question is rhetorical, only, because offering his honest response would be based on speculation and the content of the answer would be undignified.)  It is clear that COVID is going to prevent adequate FDA on-site inspections for months, if not years, and yet . . .

By Kurt R. Karst —

While receiving less public attention than some other types of health care products, in vitro diagnostics (IVDs) have for years been playing an increasingly important role in health care.  The COVID-19 pandemic has highlighted what has long been the case: IVDs are indispensable to public health.  Whether used as companion diagnostics to guide therapeutic treatment, or liquid biopsy to identify tumors from blood tests, or to detect an infectious disease, or to help determine whether a patient has had a heart attack, or in thousands of other ways, IVDs are essential in medicine.

There has not, however, been a single source that someone could consult to learn about how IVDs are regulated today.  To fill that void, the Food and Drug Law Institute (FDLI) has just released Diagnostics at a Crossroads: Navigating IVD Regulation in a Changing Environment, the first book in over a decade that addresses the world of IVD regulation.

The book comprehensively covers diagnostic regulatory issues, from premarket issues, e.g., analytical testing, statistics, clinical studies, and pathways to the market, to post-market issues, such as Quality System Regulation and Medical Device Reporting.  And, of course, it addresses two of our favorite topics: laboratory developed tests (LDTs) (see, e.g., our earlier posts here, here, here, here, here, and here) and research use only (RUO) products.  The authors represent a range of disciplines and expertise.  To name just a few, they include Dan Schultz, former director of CRRH; Nina El-Badry of BARDA; and Sally Hojvat, who was Director of one of the IVD Divisions at CDRH and now consults with WHO; and several colleagues at Hyman, Phelps & McNamara, P.C., and other law firms.  The book also covers other topics critical to IVD manufacturers and investors, such as reimbursement – simply getting on the market isn’t often enough for a test to be commercially viable – and the evolving European regulatory model.

More information about the book can be found here: https://www.fdli.org/IVD-book.

With the ongoing leaps in technology the importance of IVDs will only continue to grow.  We expect that this book will be a valuable resource for those who are seeking to learn how to better understand and navigate the world of IVD regulation.

By Karla L. Palmer —

In the waning days of the Trump administration, the Department of Health and Human Services announced a fairly significant change in addiction medicine policy. The new policy permits physicians (and only physicians) more flexibility to prescribe buprenorphine – a much used and effective drug that treats opioid use disorder.  On a side note, it has always been a “head scratcher” that it was actually much easier to prescribe highly addictive opioids (like schedule II or schedule III narcotic controlled substances) than buprenorphine, which is used for the much-needed treatment for abuse of opioids.  Until HHS’s recent announcement, any physician seeking to treat opioid use disorder with buprenorphine was required to obtain an “X” DEA number (i.e., “X waiver” or “Data 2000 waiver”).  Unless appropriately board certified, this required an 8-hour training; advanced practitioners including physician assistants and nurse practitioners need 24 hours of training.  Prescribers were also limited to 30 patients at a time within their first waiver year, and 100 patients thereafter (after meeting additional notification requirements).  We were waiting for — and wondering why — the Practice Guideline had not been been published in the Federal Register notwithstanding its release more than ten days ago, yet remained hopeful.  Enter the Biden Administration.  As published in The Washington Post, and carried by other news outlets, these practice Guidelines announced by the Trump administration in its final days “had significant legal and clinical concerns” and the Biden will not issue the Practice Guidelines that were previously announced.

As the original blogpost stated, the attached Practice Guidelines for the Administration of Buprenorphine for Treating Opioid Use Disorder exempts from certain certification requirements under 21 U.S.C. § 823(g)(2) of the Controlled Substances Act (CSA) those physicians licensed under State law and who possess a DEA registration.  Note the following important limitations on the new HHS exemption:

• The exemption only applies to physicians who may only treat patients who are located in the state or states in which they are authorized to practice medicine.
• Physicians will be limited to treating no more than 30 patients with buprenorphine for opioid use disorder at any one time (but note: the 30-patient cap does not apply to hospital-based physicians, such as emergency department physicians).
• The exemption applies only to the prescribing of drugs or formulations covered under the X waiver, such as buprenorphine, and does not apply to the prescription, dispensation, or use of methadone for the treatment of OUD (which – appropriately used — must be administered in a SAMHSA-certified program).
• Physicians utilizing this exemption shall place an “X” on the prescription and clearly identify that the prescription is being written for opioid use disorders (and separately maintain information in the chart used for the patient being treated for OUD).
• An interagency working group will be established to monitor the implementation and results of these new practice guidelines, as well as the impact on diversion.

Notwithstanding the benefit of greater access to medication assisted treatment using buprenorphine in what appears to be a thoughtful, controlled and reasonable manner, it seems like, given the new administration’s unwillingness to publish them, at least this blogger will continue to wonder why it appears easier to obtain the addictive opioid than it is t obtain the medication assisted treatment (at least the prescribing of buprenorphine) for opioid addiction.

By Karla L. Palmer —

In the waning days of the Trump administration, the Department of Health and Human Services announced a fairly significant change in addiction medicine policy. The new policy permits physicians (and only physicians) more flexibility to prescribe buprenorphine – a much used and effective drug that treats opioid use disorder.  On a side note, it has always been a “head scratcher” that it was actually much easier to prescribe highly addictive opioids (like schedule II or schedule III narcotic controlled substances) than buprenorphine, which is used for the much-needed treatment for abuse of opioids.  Until HHS’s recent announcement any physician seeking to treat opioid use disorder with buprenorphine was required to obtain an “X” DEA number (i.e., “X waiver” or “Data 2000 waiver”).  Unless appropriately board certified, this required an 8-hour training; advanced practitioners including physician assistants and nurse practitioners need 24 hours of training.  Prescribers were also limited to 30 patients at a time within their first waiver year, and 100 patients thereafter (after meeting additional notification requirements).

The attached Practice Guidelines for the Administration of Buprenorphine for Treating Opioid Use Disorder exempts from certain certification requirements under 21 U.S.C. § 823(g)(2) of the Controlled Substances Act (CSA) those physicians licensed under State law and who possess a DEA registration.  Note the following important limitations on the new HHS exemption:

• The exemption only applies to physicians who may only treat patients who are located in the state or states in which they are authorized to practice medicine.
• Physicians will be limited to treating no more than 30 patients with buprenorphine for opioid use disorder at any one time (but note: the 30-patient cap does not apply to hospital-based physicians, such as emergency department physicians).
• The exemption applies only to the prescribing of drugs or formulations covered under the X waiver, such as buprenorphine, and does not apply to the prescription, dispensation, or use of methadone for the treatment of OUD (which – appropriately used — must be administered in a SAMHSA-certified program).
• Physicians utilizing this exemption shall place an “X” on the prescription and clearly identify that the prescription is being written for opioid use disorders (and separately maintain information in the chart used for the patient being treated for OUD).
• An interagency working group will be established to monitor the implementation and results of these new practice guidelines, as well as the impact on diversion.

The new guidelines state the date on which they will take effect will be added after publication in the Federal Register.

2020 was unprecedented and tumultuous due to simultaneous challenges of a once-in-a-century global pandemic, the resulting socio-economic fallout, and political polarization regarding policy responses to the pandemic, civil rights protests and presidential elections. The FDA has been pressured and challenged and responded with varying degrees of success and now faces an incoming administration that in many ways could not contrast more sharply with its predecessor.

Join the all-star panel of FDA consultants and lawyers, including HPM’s own Frank Sasinowski in a discussion and Q&A of the 2020 experience and the FDA outlook for 2021 and beyond. To register, please click here.

By Serra J. Schlanger & Michael S. Heesters & Alan M. Kirschenbaum —

As we previously reported (see here and here), in three separate cases, federal courts blocked the implementation of the Most Favored Nation (MFN) rule for Medicare Part B drug payment.  (Our summary of the MFN rule is available here.)  In December 2020, the District Court for the Northern District of California and the District Court for the Southern District of New York issued nationwide preliminary injunctions, while the District Court for the District of Maryland issued a temporary restraining order.  Each order effectively blocked the MFN rule from taking effect on January 1, 2021.

On January 13, 2021, Judge George J. Hazel granted a stay in the suit filed in the District Court for the District of Maryland.  As explained in the Joint Motion to Stay, the plaintiffs (the Association of Community Cancer Centers, the National Infusion Center Association, the Global Colon Cancer Association, and PhRMA) and government defendants agreed to stay the litigation until a new final rule is published in the Federal Register, based on “(1) Defendants’ agreement that they will not appeal the preliminary injunction issued by the Northern District of California; and (2) Defendants’ agreement that the performance period for any final regulation … shall not commence earlier than 60 days after publication of that regulation in the Federal Register.”  We note that, in a fourth lawsuit challenging the MFN rule, the government filed a Status Report on January 8, notifying the District Court for the District of Columbia that it will not appeal the nationwide preliminary injunctions issued by the District Courts in the Northern District of California and Southern District of New York.

A new administration has taken over since these court developments.  Based on what we’ve seen so far, including the Biden White House’s “Regulatory Freeze Pending Review” memo issued on January 20, we can safely say the MFN Rule published in November 2020 will not take effect in the short term.  We can also confidently predict that, if and when a new MFN rule is introduced, it will be in the form of a proposed rule with an opportunity for public comment.  More difficult to predict is whether an international reference pricing model will fit into the overall drug price reduction strategies of the new administration and Congress.