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FDA’s Unapproved Drugs Initiative Revived, with Gusto!

Although we’ve now entered June of 2021 and President Biden has yet to nominate someone to serve as the Commissioner of Food and Drugs, current Acting Commissioner Janet Woodcock and her Senate-confirmed boss, Department of Health and Human Services (HHS) Secretary Xavier Becerra, have wasted no time reviewing and revoking regulatory actions implemented in the waning days of the prior Administration’s tenure in charge of the Executive Branch. As we reported in April, the two leaders co-signed a decision to reverse January 2021 actions by the Trump Administration to exempt a large number of medical device types from Food and Drug Administration (FDA) premarket review, noting in their rationale that not only was FDA not consulted in the prior action but HHS’s original determinations “lacked adequate scientific support, contained multiple errors, and were ultimately flawed.”

On May 27, a similar reversal notice with strikingly similar language about the lack of FDA input or the inclusion of appropriate regulatory expertise in the decision-making process – and once again co-signed by Secretary Becerra and Dr. Woodcock – was published in the Federal Register. The target this time was the prior Administration’s announcement in November 2020 that it was withdrawing all FDA guidance documents prepared and issued as part of the agency’s Unapproved Drugs Initiative (UDI) and terminating the UDI program; that termination notice cited drug costs and competition-related concerns as well as the FDA’s failure to develop and announce the UDI through notice-and-comment rulemaking. We discussed this surprise action by the prior HHS leadership in our 2020 year-in-review blog post and speculated whether a more consumer-protective Department led by Secretary Becerra would be likely to reverse course (see here).

In particular, in the recent withdrawal-of-the-termination notice, Secretary Becerra and Dr. Woodcock point out that:

  • "We did not find any evidence that HHS consulted with, otherwise involved, or even notified FDA before issuing” the November 2020 UDI termination notice, even though the delegation of authority in the Food, Drug and Cosmetic Act (FD&C Act) provides that the Secretary is responsible for executing the Act “through the Commissioner”;

  • The UDI termination notice misinterpreted the statutory term “new drug” by not distinguishing between active ingredients and drug products, therefore advancing significant legal inaccuracies;

  • The UDI termination notice also included multiple factual inaccuracies derived from its cherry-picking of information on price increases for certain prescription drugs (for example, in one case, the price increase HHS used as an example had nothing to do with the UDI since the drug in question was approved well before the program was created); and

  • Characterizing the UDI as a new agency policy that should have been adopted through notice-and-comment rulemaking was “erroneous” because FDA’s guidance documents did not alter any existing interpretations of the Act or the agency’s authorities to take action against unapproved new drugs. And, importantly, “communicating enforcement policies through guidance documents rather than legislative rules is consistent with both the Administrative Procedure Act and FDA’s regulations on good guidance practices” (internal citations omitted), which both recognize that the agency can notify the public about its enforcement policies and procedures without going through a lengthy rulemaking process.

Current HHS and FDA leadership conclude, based on all of those points, that:

The UDI termination notice “does not accurately reflect [HHS’s] or FDA’s thinking because it is inconsistent with the FD&C Act, FDA regulations, and judicial precedent, among other legal authorities, and is not supported by the facts. In addition, [it] could result in significant harm to public health by suggesting that unsafe or ineffective drugs could circumvent the drug approval process.”

They also note – for extra measure – that “neither HHS nor FDA has the authority to exempt a product or class of products that are new drugs under the FD&C Act from the new drug approval requirements of the FD&C Act.” (That being the exclusive purview of Congress in promulgating our federal laws and giving express grants of authority to administrative agencies.)

The agency also stated that it would issue new guidance on its unapproved drug enforcement priorities, given the recognition by Secretary Becerra and Dr. Woodcock that the November 2020 UDI termination notice may have created confusion for members of regulated industry. They also indicated that the revised policy document will “provide appropriate updates” regarding FDA’s goals in this area. The UDI program was initially launched in 2006, and its most recent guidance document was in 2011, so a refreshed version will certainly be welcome given the significant changes to the health care marketplace over the past decade.

And perhaps most importantly, companies and individuals who may have launched new unapproved drug products in the time since the HHS withdrawal notice was published in 2020 – as well as entities that invested in such companies marketing unapproved products – should reassess their risk tolerance for potential government enforcement action in light of this forceful and clear reinstatement of FDA’s interpretation of the law and its policies. Keep an eye on the Federal Register for when this promised and exciting new guidance document is shared with the public!

©1994-2022 Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. All Rights Reserved.National Law Review, Volume XI, Number 158
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About this Author

Joanna Hawana, Mintz Levin, FDA Lawyer, Clinical Trials & Research Consumer Product Safety FDA Regulatory Health Care Compliance, Fraud & Abuse, and Regulatory Counseling Health Care Transactional Due Diligence
Of Counsel

Joanne counsels global clients on regulatory and distribution-related considerations to bringing a new FDA-regulated product to market and how to ensure continued compliance after a product is commercialized. She also advises on the business impact of new US federal and state actions that affect those regulated products, such as drugs, foods, cosmetics, electronic nicotine delivery systems, and medical devices, including in vitro diagnostics, lab tests, and mobile medical applications. In recent years she has been advising clients in different industries regarding FDA’s approaches to...

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