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The U.S. Department of Health and Human Services (HHS) announced in a federal register notice the ending of the Food and Drug Administration (FDA) Unapproved Drugs Initiative (UDI) in an effort to deal with the rising costs of prescription drugs.

HHS announced that it was withdrawing FDA’s Marketed Unapproved Drugs – Compliance Policy Guide, Sec. 440.100, Marketed New Drugs Without Approved NDAs or ANDAs and was requesting information from the public regarding the status of old drugs that could qualify as grandfathered drugs or drugs that were Generally Recognized as Safe and Effective (GRAS/E). The withdrawal of this guidance is effective 30 days after publication of HHS’s notice in the Federal Register, which is December 25, 2020. 

As HHS describes the history of the UDI, FDA launched the UDI in 2006 without notice-and-comment rulemaking, which gave HHS “serious legal concerns about whether the UDI was implemented through legally permissible procedures.” The UDI program was created to reduce the number of unapproved drugs on the market. In an effort to encourage companies to obtain approval for unapproved drugs, FDA would give the approved owner a period of “de facto market exclusivity” before the other drugs obtained approval. HHS noted that this period of exclusivity allowed for the owners to raise prices on older drug products while being insulated from market competition. A study of 34 drugs subject to the UDI found that the wholesale price of 26 of the 34 drugs increased a median of 37% and the average wholesale unit price of 11 of the drugs increased by more than 128%. This study also suggested that the UDI led to drug shortages.

HHS is asking for the following information from patients, healthcare providers, industry, and other stakeholders:

  1. Lists of drugs marketed prior to June 25, 1938 that are currently available on the market.
  2. The extent to which drugs marketed prior to June 25, 1938, or drugs that might qualify as GRAS/E, have regulatory approvals in countries outside the United States.
  3. Whether there would be adverse clinical or economic consequences to deeming as GRAS/E those drugs previously approved by the FDA for which patent and regulatory exclusivity have expired.
  4. Any published literature reviews or clinical studies related to any drugs potentially exempt from the new drug approval requirement.

Because this ending of the UDI is a radical departure from FDA’s previous position, the new Biden administration may not be as supportive of this move. Therefore, it is unsure whether this recent departure from FDA’s previous position will remain once new leadership takes over HHS. Regardless, stakeholders that are dealing with the UDI should get their comments into HHS if they want to influence the new path of unapproved drugs at FDA.

Additional Resources From HHS

HHS notice on ending UDI - https://www.govinfo.gov/content/pkg/FR-2020-11-25/pdf/2020-26133.pdf

HHS statement on UDI - https://www.hhs.gov/about/news/2020/11/20/statement-hhs-chief-staff-brian-harrison-unapproved-drugs-initiative.html

HHS and FAQ on UDI - https://www.fdalawblog.net/wp-content/uploads/2020/11/covid-19-unapproved-drugs-initiative.pdf