FDA provides guidance on generic drug updates after withdrawal of reference product


FDA Issuing New Guidance On Generic Drug Labels

Earlier this month, the US Food and Drug Administration (FDA) released new draft guidance for the general pharmaceutical industry on the process of updating the labeling on a drug after the reference product is withdrawn for any reason other than safety.

Generic drugs companies have long faced issues regarding this topic. By law, generic drug labels are required to be the same as their reference product counterparts at the time of approval. However, sometimes this labeling relies on drugs that have been withdrawn from the product for monetary reasons.

As things stand, all independent generic drug makers are not able to independently update their product labels upon learning of new safety information, nor are they able to warn the public of their concerns. For brand-name drug-makers, it’s a different story; they have been free to update their labels without seeking any approval from the FDA.

The main objective of the new draft guidance is to ensure that all labels are updated with new information as quickly as possible to reflect changes – ultimately to ensure greater safety of those that use them. It’s about giving the drug-makers this responsibility. “All holders of marketing applications for drug products (both NDAs and ANDAs) have an ongoing obligation to ensure their product labeling is accurate,” says the FDA.

However, the FDA’s proposed regulations are controversial, and the issue has remained under hot debate by drug companies for many years. Under the new legislation, courts could find generic drug-makers liable for injuries or harm caused to users as a result of failing to update the information on their labels. This is by no means the first attempt by the FDA to bring in similar legal requirements. Previous attempts by the FDA to introduce such regulations have been unsuccessful, as lobbyists have managed to put a stop to them. This latest attempt could also still meet the same fate; there is now a 60 day public consultation period to go through before the draft guidance can become approved.

In the new 12-page draft’s favor, it is more detailed than previous propositions, offering more guidance for generic companies on when and under what circumstances they must update drug labels. Offering a more defined process for generic companies could be enough this time to see the draft approved – time will tell.





Wilson Sonsini Goodrich & Rosati is the premier legal advisor to technology, life sciences, and other growth enterprises worldwide. In today’s fast-growing, highly regulated generic pharmaceutical market, companies require specialized legal guidance beyond the scope of general corporate and securities counsel. WSGR has an experienced team of experts in key practice areas, including intellectual property, litigation, antitrust, FDA/regulatory, technology transactions, exports and FCPA, trade secret, and trademark and copyrights. Learn more at www.wsgr.com

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