Health Law Advisor

“Master Files” are not just for PowerPoints. On April 4, 2024, the Food and Drug Administration (FDA) issued its “New Dietary Ingredient Notification Master Files for Dietary Supplements: Guidance for Industry” (“Draft Guidance”). These latest recommendations build upon the agency’s Final Guidance issued in March—the subject of our prior blog post—regarding procedures and timeframes for industry stakeholders to submit NDINs. The new recommendations also replace and expand upon those portions of a 2016 Revised Draft Guidance, called “Dietary ...

On March 5, 2024, the Food and Drug Administration (FDA) issued its “Dietary Supplements: New Dietary Ingredient Notification Procedures and Timeframes: Guidance for Industry” (“Final Guidance”). The purpose of the Final Guidance is to assist manufacturers and distributors of new dietary ingredients (“NDIs”) and dietary supplements in preparing and submitting new dietary ingredient notifications (“NDINs”) to the FDA.

The Final Guidance finalizes Section V, “NDI Notification Procedures and Timeframes,” of a 2016 revised Draft Guidance (“Draft ...

A federal appeals court panel in New Orleans is poised to uphold a lower court ruling enjoining the enforcement of the Affordable Care Act's (ACA) requirement that most private health insurance cover recommendations of the United States Preventive Services Task Force (Task Force).

On March 4, 2024, the U.S. Court of Appeals for the Fifth Circuit heard oral arguments in Braidwood v Becerra, a case challenging the constitutionality of the ACA requirement that most forms of private health coverage include certain recommended preventive services. The panel of three judges ...

From our Thought Leaders in Health Law video series: Braidwood v. Becerra represents a significant legal challenge to the Affordable Care Act’s (ACA’s) preventive services coverage provision, which requires private health insurance to cover various clinical preventive services, including immunizations; services rated A or B by the U.S. Preventive Services Task Force; and women's preventive services, such as contraceptives.

Employer plaintiffs have contested the law on moral and religious grounds, particularly objecting to coverage for HIV prevention medication ...

Whether a consumer is taking calcium carbonate for strong bones, magnesium to fall asleep, or high-dose caffeine to stay awake, the U.S. Food and Drug Administration (FDA) does not approve dietary supplements for safety and effectiveness. So how do consumers know if a product is safe, and how can manufacturers protect themselves in the case of a problem?

In response to stakeholder feedback, the FDA on February 21, 2024, released its updated directory of FDA actions and communications with respect to “Information on Select Dietary Supplement Ingredients and Other Substances.”

As of September 25, 2023, Bill A4151 was approved by the New Jersey Senate and is now law in New Jersey. This approved bill amends the existing New Jersey recreational cannabis regulatory landscape. Bill A4151, or P.L. 2023, c.162, (the “Amendment”) revises and waives certain restrictions currently imposed on owners of cannabis establishments. Prior to the enactment of the Amendment, Class 5 retail license holders and their owners, were prohibited from holding interest in other Class 5 retail licenses because horizontal expansion is otherwise prohibited under the state’s ...

In this episode of the Diagnosing Health Care Podcast: The U.S. Food and Drug Administration’s (FDA’s) broad definition of “misbranding” has created some industry confusion, while the Federal Trade Commission’s (FTC’s) updates to its Health Products Compliance Guidance have done the same.

In light of these recent actions, what challenges are dietary supplement manufacturers now facing?

On this episode, Epstein Becker Green attorneys Jack Wenik, Teddy McCormick, Zach Taylor, and Tracey Gonzalez discuss recent updates to the FDA and FTC guidelines as they apply to ...

On October 31, 2023, FDA hosted a webinar to address some of the frequently asked questions the agency has received since the September 29, 2023 release of its proposed rule on laboratory developed tests (“LDTs”). The materials from the webinar are available on FDA’s CDRH Learn webpage. Importantly, FDA announced during the webinar that the agency does not currently plan to extend the comment period for the proposed rule beyond the standard 60-day timeframe, and therefore, comments are still due on Monday December 4, 2023. In both the preamble to the proposed rule and stated ...

The latest attempt to expand the psychedelic world is making its way through Congress. On September 21, 2023, Congressmen Robert Garcia (CA-42)  and Earl Blumenauer (D-OR) introduced the “Validating Independence for State Initiatives on Organic Natural Substances Act of 2023”. Aptly titled the VISIONS Act, this legislation would, if enacted, protect legal psilocybin use from federal law enforcement intervention in any state or locality where psilocybin is legally permitted. The language in the Act specifically states that it aims to prohibit any federal funds from being ...

From our Thought Leaders in Health Law video series: The Inflation Reduction Act (IRA) introduces significant changes in prescription drug pricing, including the establishment of the Medicare Drug Price Negotiation Program and the Medicare Prescription Drug Inflation Rebate Program to control drug prices.

The IRA includes a redesign of the Medicare Part D benefit, which began with the announcement of 10 Medicare Part D drugs open for negotiation. This video highlights the challenges and complexities during the multi-year IRA implementation and emphasizes the penalties for ...

In a last minute push before an anticipated government shutdown, FDA put down its marker for moving forward toward regulation of lab developed tests (“LDTs”). Unlike past proposals from FDA and Capitol Hill, FDA has taken a simple approach: laboratories that make LDTs for clinical use are manufacturing in vitro diagnostic medical devices (“IVDs”) for commercial distribution, and as such must eventually comply with FDA’s already-established IVD requirements. The FDA zeitgeist boils down to this: It doesn’t matter if the lab is large or small, for profit or ...

In this episode of the Diagnosing Health Care Podcast:  Throughout this series, we've talked about the growth of the direct access testing industry and the types of models developed to support the businesses that are using that type of testing.

We've covered reimbursement considerations and physician ordering and specimen collection regulations. How does all of this come together to shape the future of the lab testing industry?

On the final episode of our four-part series on direct access laboratory testing, Epstein Becker Green attorneys Bob Hearn, James ...

In this episode of the Diagnosing Health Care Podcast:  In July, the Centers for Medicare & Medicaid Services made significant headway in its implementation of the drug pricing provisions of the Inflation Reduction Act (IRA).

How can stakeholders respond to, implement, and comply with all these new provisions? On this episode, hear from special guest Sylvia Yu, Vice President and Senior Counsel of Federal Programs at PhRMA.

Sylvia and Epstein Becker Green attorneys Connie Wilkinson and Alexis Boaz discuss the recent updates on the quickly moving implementation of the drug pricing provisions under the IRA and the industry’s response.

As discussed in our June Insight, earlier this year FDA publicly announced its development of a proposed rule that would expressly define laboratory developed tests (“LDTs”) as medical devices and subject them to the agency’s regulatory authority. Such a rule would be FDA’s first comprehensive attempt to impose its authority over LDTs since its 2014 draft guidance, which FDA ultimately chose not to finalize, and comes after several failed congressional legislative attempts to do the same.

In this episode of the Diagnosing Health Care Podcast:  A complex landscape of state laws overlays the direct access testing model, ranging from physician order requirements, such as telemedicine standards and the corporate practice of medicine doctrine, to specimen collection considerations, including how the varying options for collection could impact a model.

How do these factors combine to create a roadmap for companies navigating the direct access testing industry?

In this episode of the Diagnosing Health Care Podcast:  Renewed interest in the potential benefits of psychedelic treatments has led to an upsurge in research. Is the first FDA approval of a psychedelic for therapeutic use on the horizon?

In this episode of the Diagnosing Health Care Podcast:  What has contributed to the biotechnology industry’s explosive growth over the last several years? In this episode, special guests Don and Lisa Drakeman, two former CEOs of biotech companies, reflect on what it takes to succeed, the regulatory challenges they have faced, and how current events are shaping the future of the industry.

The United States Food and Drug Administration (FDA) for many years has been trying to increase the participation of minorities in clinical trials to help ensure that regulated products are tested and labeled in an appropriate cross-section of Americans.  Clinical evidence has shown that there are significant differences among the races that impact the safety and effectiveness we can expect from a particular drug or device, and consequently FDA has concluded testing and labeling to identify those racial differences are important.  The question for today is, how are we doing in achieving racial diversity in clinical trials involving drugs?

It is common for FDA and others to show a map of the United States with the states color-coded by intensity to showcase the total number of inspections done in that state.  Indeed, FDA includes such a map in its newly released dashboard for FDA inspections.  In reviewing that map with the U.S. map color-coded to reflect where medical device establishments are located, do you notice anything?  Not to destroy the suspense for you, but it turns out that FDA tends to inspect where medical device inspection facilities are located.  Really.

We wanted to get beneath those numbers in two ways.  First, it’s much more informative to look at the data at a county level because there’s actually quite a bit of variation county by county.  Second, and more importantly, we wanted to normalize the inspection data by the number of facilities.  In other words, by looking at inspections per facility, we can get a better sense of the inspection frequency in each county.

On June 21, 2021, Florida Governor Ron DeSantis signed into law a bill requiring genetic counselors to be licensed by the Florida Department of Health (“FLDOH”).  The new law, known as the Genetic Counseling Workforce Act (“GCWA”), became effective on July 1, 2021.  FLDOH has announced a 90 day enforcement moratorium to allow counselors time to become appropriately licensed in the State.  Florida now joins a growing number of states that regulate the work of genetic counselors.

On Tuesday, September 1, 2020, the Drug Enforcement Agency (“DEA”) proposed 2021 aggregate production quotas (APQs) for controlled substances in schedules I and II of the Controlled Substances Act (“CSA”) and an Assessment of Annual Needs (“AAN”) for the List I Chemicals pseudoephedrine, ephedrine, and phenylpropanolamine. This marks the second year that DEA has issued APQs pursuant to Congress’s changes to the CSA via the SUPPORT Act.  After assessing the diversion rates for the five covered controlled substances, DEA reduced the quotas for four: oxycodone, hydrocodone, hydromorphone and fentanyl.

DEA recently increased the APQ to allow for the additional manufacture of certain controlled substances in response to the COVID-19 pandemic and the need to provide greater access to these medications for patients on ventilator treatment.  According to DEA, that increased demand has been factored into the proposed APQs for 2021.

Comments are due by October 1, 2020.  Because DEA’s APQs determine the amount of quota DEA can allocate to individual manufacturers in 2021, adversely impacted parties should file comments soon.

Background on APQs

The CSA requires the establishment of aggregate production quotas for schedule I and II controlled substances, and an assessment of annual needs for the list I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine.  These aggregate quotas limit the quantities of these substances to be manufactured – and with respect to the listed chemicals, imported –  in the United States in a calendar year, to provide for the estimated medical, scientific, research, and industrial needs of the United States, for lawful export requirements, and for the establishment and maintenance of reserve stocks.

Changes in Setting APQs Under The SUPPORT Act

The Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act (“SUPPORT Act”) signed into law October 24, 2018, provided significant changes to the process for setting APQs.  First, under the CSA, aggregate production quotas are established in terms of quantities of each basic class of controlled substance, and not in terms of individual pharmaceutical dosage forms prepared from or containing such a controlled substance.  However, the SUPPORT Act provides an exception to that general rule by giving the DEA the authority to establish quotas in terms of pharmaceutical dosage forms if the agency determines that doing so will assist in avoiding the overproduction, shortages, or diversion of a controlled substance.

Additionally, the SUPPORT Act changed the way the DEA establishes APQs with respect to five “covered controlled substances”: fentanyl, oxycodone, hydrocodone, oxymorphone, and hydromorphone.  Under the SUPPORT Act, when setting the APQ for any of the “covered controlled substances,” DEA must estimate the amount of diversion.  The SUPPORT Act requires DEA to make appropriate quota reductions “as determined by the [DEA] from the quota the [DEA] would have otherwise established had such diversion not been considered.”  Furthermore, when estimating the amount of diversion, the DEA must consider reliable “rates of overdose deaths and abuse and overall public health impact related to the covered controlled substance in the United States,” and may take into consideration other sources of information the DEA determines reliable.

Estimating Diversion  

In accordance with this mandate under the SUPPORT Act, in setting the proposed APQs for 2021 DEA requested information from various agencies within the Department of Health and Human Services (“HHS"), including the U.S. Food and Drug Administration (“FDA”), Centers for Disease Control and Prevention (“CDC”), and the Centers for Medicare and Medicaid Services (“CMS”), regarding overdose deaths, overprescribing, and the public health impact of covered controlled substances.  DEA also solicited information from each state’s Prescription Drug Monitoring Program (“PDMP”), and any additional analysis of prescription data that would assist DEA in estimating diversion of covered controlled substances.

After soliciting input from these sources, DEA extracted data on drug theft and loss from its internal databases and seizure data by law enforcement nationwide.  DEA then calculated the estimated amount of diversion by multiplying the strength of the active pharmaceutical ingredient (“API”) listed for each finished dosage form by the total amount of units reported to estimate the metric weight in kilograms of the controlled substance being diverted.

FDA recently published its “Good Manufacturing Practice Considerations for Responding to COVID-19 Infection in Employees in Drug and Biological Products Manufacturing Guidance for Industry” (“Guidance”) which provides suggestions on managing the potential risk of products being contaminated by SARS-CoV-2, the virus behind COVID-19 infections for drug and biological product manufacturers, 503B outsourcing facilities, and 503A compounding pharmacies.

The Guidance builds on the current Good Manufacturing Practices (cGMPs) regulations for drugs and biological products, which require personnel with an illness that could adversely affect drug safety or quality be excluded from direct contact with drugs and drug components used in manufacturing.[1]  As the Guidance states, preliminary research indicating that SARS-CoV-2 “is stable for several hours to days in aerosols and on surfaces,” and that it has an incubation period of 2 to 14 days, which are both factors that increase the risk of spread and introduction into products.  The actual health risk is hard to calculate – FDA itself notes that there have not been documented transmissions through pharmaceuticals to date.  The regulatory risk, however, is an easier formula – FDA has a clear expectation that drug and biological product manufacturers evaluate the potential for COVID-19 contamination of their products under existing controls, or risk being out of compliance with cGMPs.

On May 31, 2019, the U.S. Food and Drug Administration (“FDA”) hosted its much-anticipated public hearing titled “Scientific Data and Information about Products Containing Cannabis or Cannabis-Derived Compounds” (discussed in our prior blog post). The day-long hearing presented an opportunity for FDA panel members to engage directly with stakeholders on the regulatory future of cannabis or cannabis-derived products within the scope of FDA’s jurisdiction.

Acting FDA Commissioner Ned Sharpless, M.D., kicked off discussions, reminding the panel and ...

On February 15, 2019, the U.S. Food and Drug Administration (“FDA”) finalized two guidance documents regarding regenerative medicine therapies (see FDA’s announcement here). This development comes nearly 14 months after FDA issued both guidance documents in draft form, which also coincided with FDA’s announcement of a new comprehensive regenerative medicine policy framework intended to spur innovation and efficient access to new regenerative medicine products.

FDA Commissioner Scott Gottlieb remarked that the finalization of regenerative therapy guidance ...

On February 11th, blockchain advocates, digital health enthusiasts, and patients received positive news from the Center for Medicare and Medicaid Services (“CMS”) and the Office of the National Coordinator for Health Information Technology (“ONC”) regarding patient data sharing.  These rules, taken together, seek to make data more liquid, which can promote patient access, continuity of care, research, collaboration across the industry and several other activities that previously faced challenges within a health care system built on data silos.

First, CMS ...

GenomeDx Biosciences Corp., which markets a genomic test (Decipher®) intended to assess the aggressiveness of prostate cancer, has agreed to pay $1.99 million to the U.S. Department of Justice to resolve allegations that it violated the False Claims Act (31 U.S.C. §§ 3729 et seq.)(“FCA”) by submitting claims to Medicare for tests conducted to evaluate treatment options for men after prostate surgery.

The government and a whistleblower alleged that between September 2015 and June 2017, GenomeDx knowingly submitted Medicare reimbursement claims for the Decipher® test ...

Data is king!  A robust privacy, security and data governance approach to data management can position an organization to avoid pitfalls and maximize value from its data strategy. In fact, some of the largest market cap firms have successfully harnessed the power of data for quite some time.  To illustrate this point, the Economist boldly published an article entitled “The world’s most valuable resource is no longer oil, but data.”  This makes complete sense when research shows that 90% of all data today was created in the last two years, which translates to approximately 2.5 ...

Did you know that your zip code is a better predictor of your health than your genetic code? Public health experts – and your health insurance provider – have long known that the air you breath, the education you receive, your net worth, and even the music that you listen to are strong indicators of your overall health – and the possibility that you might need expensive medical procedures in the future. By some measures, up to 50% of your overall health is determined by social, economic, and environmental factors. As the movement to value-based payment continues in health care, there ...

On August 31, 2016, FDA issued a notification of public hearing and request for comments on manufacturer communications regarding unapproved uses of approved or cleared medical products. The hearing will be held on November 9-10, 2016, and individuals wishing to present information at the hearing must register by October 19, 2016. The deadline for written comments is January 9, 2017.

In the notice, FDA posed a series of questions on which it is seeking input from a broad group of stakeholders, including manufacturers, health care providers, patient advocates, payors, academics ...

On May 19^th, the FDA again postponed publication of the Final Rule entitled, "Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products" to April 2017 (the "Final Rule").  On May 19^th, the House of Representatives Committee on Appropriations approved the 2017 Agriculture Appropriations bill, which includes provisions within Section 747 expressly defunding any efforts by the FDA to enact the rule. The Notice of Proposed Rule-Making ("NPRM") was originally published in November 2013 to provide generic drug and biologics manufacturers ...

On May 17, 2016, FDA issued Draft Guidance for Industry on Use of Electronic Health Record Data in Clinical Investigations ("Draft Guidance").  This Draft Guidance builds on prior FDA guidance on Computerized Systems Used in Clinical Investigations and Electronic Source Data in Clinical Investigations, and provides information on FDA's expectations for the use of Electronic Health Record ("EHR") data to clinical investigators, research institutions and sponsors of clinical research on drugs, biologics, medical devices and combination products conducted under an ...

By Alan J. Arville, Constance A. Wilkinson and Selena M. Brady

The House of Representatives Energy and Commerce Committee ("the Committee") circulated draft language to include in its 21^st Century Cures legislation earlier this week to reform the 340B drug discount program (the "340B Program"). Although the draft 340B language was pulled from the legislation yesterday, the language proposed provides insight into what future legislative reform may include. The draft language, if adopted, would have a substantial impact on all 340B Program stakeholders, including, covered ...

By Constance Wilkinson, Alan Arville, and Jonathan Hoerner

On July 23, 2014, the Health Resources and Services Administration ("HRSA") issued an "interpretive rule" entitled "Implementation of the Exclusion of Orphan Drugs for Certain Covered Entities under the 340B Program" (the "Interpretive Rule").[1] The Interpretive Rule follows the ruling by the U.S. District Court for the District of Columbia on May 23, 2014, that vacated the final rule previously released by HRSA on the treatment of orphan drugs under the 340B program (the "Final Rule").[2]

By way of background, the 340B ...

The Physician Payment Sunshine Act, which was incorporated into Section 6002 of the Affordable Care Act, requires pharmaceutical, medical device, biological and medical supply manufacturers to file annual reports on payments to physicians and teaching hospitals. Despite the requirement in the law that manufacturers submit their first report in March 2013 disclosing payments made during 2012, two events have pushed back that obligation or taken the sting out of noncompliance.

First, although Centers for Medicare & Medicaid Services (CMS) was required to publish standards for ...

As the health care world awaits the Medicare Shared Savings Program regulations expected to be issued soon by CMS, below is a wish list for key attributes that I hope the regulations evidence:

1. Flexibility. 

 "Transforming health care everywhere starts with transforming it somewhere." I hope that CMS takes Atul Gawande's advice and avoids being too proscriptive in launching the Share Savings Program. To me, the biggest risk to the program is being deemed a failure for having gone down too narrow a path that turns out to be unsuccessful.

Useful approaches have been suggested for ...