New Senate Bill Proposes Supply Chain Requirements for Drug Firms, Mandatory Recall Authority for FDA

A bill introduced in the Senate in early August would amend the Food, Drug and Cosmetic (FD&C) Act to provide FDA with new monetary penalty and recall tools and require drug firms to audit and document the steps in their product ingredient supply chains.

The Drug Safety and Accountability Act of 2010 was introduced in the Senate in early August by Michael Bennet (D-CO), and has the same title as the 2008 bill (S.3409) sponsored by the late Edward Kennedy (D-MA), which did not move beyond the committee stage.  The provisions in the new bill use somewhat different language but are directed at a similar range of objectives to those in the Kennedy bill.

Spurred by a recent voluminous recall by J&J of children’s products,  which was the subject of Congressional hearings in May (IPQ “In the News” June 2), deaths from tainted heparin in 2007 and 2008, which also drew Congressional hearings (IPQ May/June 2008 Report), and concerns that “up to 80%” of active pharmaceutical ingredients (API) are manufactured in countries where regulatory oversight does not meet the US standards, the bill seeks to tighten oversight and accountability to help safeguard the domestic drug supply.

Major provisions of the bill include:

● a requirement for drug firms to have a “quality management plan” covering detailed documentation of materials and API supply chains

● FDA establishment of a tracking system listing all plants supplying API or drug products to the US

● FDA pursuit of cooperative and mutual recognition agreements with overseas regulatory agencies

● a new focus on over-the-counter (OTC) products

● mandatory recall authority for FDA

● FDA subpoena power during investigations

● civil penalties for failure to comply with the new provisions, and

● whistleblower protection.

[More detail on the contents of the proposed bill and a link to the bill is provided for subscribers here.]