FDA and Generic Drug Industry Close to Deal in Foreign Oversight Management

By Mike Rozembajgier

A growing number of pharmaceutical companies are relying on overseas plants to supply ingredients for their prescription drugs. As previously detailed by ExpertINSIGHTS, the result is a complex network of foreign supply chains that pose significant challenges for the Food and Drug Administration (FDA), which has already found itself underfunded and unprepared for the tasks it is assigned.

With over 80 percent of the active ingredients found in drugs sold in the U.S. now sourced from foreign plants, patients are increasingly at risk of illness and death from generic medicines that may be contaminated, either accidentally or on purpose. These foreign plants are exempt from the inspections and regulations to which domestic manufacturers are subject.

According to a recent New York Times article, this all may soon change. A new agreement expected to be completed within weeks will have generic drug companies paying $299 million annually to underwrite third party inspections of foreign manufacturing plants every two years, the same frequency required of domestic plants.

The new agreement not only will help alleviates the FDA’s growing oversight burden, but will also benefit drug manufacturers by offering speedier product approvals. The median approval time for generic medicines is now 31 months.  If this new agreement is implemented, the approval time is expected to come down to only ten months.  In addition, more frequent and comprehensive inspections will help companies avoid product recalls which impact the confidence of the pharmaceutical industry as well as consumers here in the U.S.

Once implemented, this deal will be a big step toward increased drug safety by allowing government inspection earlier in the supply chain.  Incidents like the 2008 Heparin tampering may now be avoidable.

This deal only applies to generic prescription drug manufacturers. The inspection process for over-the-counter medicines and name-brand medicines will not change.  But generic drugs now account for almost 75 percent of the American prescription pharmaceutical market.  Many consumers, hospitals and doctors will appreciate the increased safety.

If this agreement is successful, it may open the door to better cooperation between the FDA and the makers of name brand and over-the-counter drugs and increased safety for their customers.

In the meantime, this proposal is a big step by generic pharmaceutical companies to ensure their commitment to consumer safety.  In an interview with the Times, Dr. Margaret Hamburg, commissioner of the FDA, said “If a program along the lines of what the parties are working on is enacted by Congress, it would represent a real breakthrough,” placing the FDA’s generic drug program on a “much more stable footing.”

This proposal is also a big step forward for the FDA, as the agency looks for ways to mitigate the inherent risks of the global marketplace and protect consumers from contaminated drugs.

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