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By December 18, 2020FDA

Unapproved Drugs Initiative Terminated

On November 20, 2020 The Department of Health and Human Services terminated the Unapproved Drugs Initiative.

The 2006 Unapproved Drug Initiative requires manufacturers to submit drugs that entered the market prior to 1938 and prove to the Food and Drug Administration (FDA) that they are safe. The first company to gain approval of a drug that had already been in use could earn up to seven years of patent protection.  This patent protection caused significant price hikes in several older, essential drugs.

Terminating this Initiative closes this loophole and everts back to the FDA’s prior approach to unapproved drugs.  Essentially, manufacturers still need to register with the FDA, list their products and follow the Current Good Manufacturing Practices

Three Industry Groups File Lawsuit to Stop Drug Importation

Pharmaceutical Research and Manufacturers of America, Partnership for Safe Medicines and the Council for Affordable Health Coverage filed a lawsuit in November to block a rule allowing drugs to be imported.

In July President Trump signed an executive order to allow states, wholesalers and pharmacies to import FDA-approved drugs from other countries where drug prices are lower. The lawsuit says the rule ignores certain patient safety protections and provides no evidence that drug costs would in fact be lower.

In addition, the Canadian Health Minister signed an order to limit import of drugs to the United States in order to avoid drug shortages in Canada.