Key players in the US House of Representatives have put on the table a draft of comprehensive legislation aimed at strengthening FDA’s recall and overseas inspection authorities and requiring new supply chain accountability for drug companies. The bill is intended to help FDA respond to the increasing challenges it faces in regulating a global pharmaceutical marketplace.
John Dingell (D-MI), Chairman Emeritus of the Energy and Commerce Committee, Henry Waxman (D-CA), Chairman of the Energy and Commerce Committee, Frank Pallone (D-NJ), Chairman of the Subcommittee on Health, and Bart Stupak (D-MI), Chairman of the Subcommittee on Oversight and Investigations, released a discussion draft of the legislation on September 20. The draft builds on H.R. 759, the Food and Drug Globalization Act, which was introduced by Dingell, Pallone and Stupak last year, and reflects the “priorities and recommendations” of FDA.
The proposed bill: ● requires “parity” between foreign and domestic drug facility inspections ● increases the number of pre-approval drug inspections ● prohibits the entry of drugs into the United States lacking documentation of safety ● requires manufacturers to ensure the safety of their supply chain, and ● grants FDA authority to mandate recalls of unsafe drugs.
In introducing the draft, the four House Committee Chairs emphasized the importance of providing FDA with the authority it needs to ensure that products imported into the US from foreign manufacturers are as safe and effective as their American counterparts. “We cannot continue to allow foreign manufacturers to produce drugs for the American people without granting the FDA strong regulation authority and enforcement tools over these entities,” Stupak emphasized.
The sponsors will be working with members of the Energy and Commerce Committee and stakeholders to refine the legislative draft. The portions of H.R. 759 concerning food safety were the basis of a separate bill, H.R. 2749, the “Food Safety Enhancement Act,” which passed the House by a 283-142 vote last summer.
The new House bill accompanies two other bills, recently introduced into the House and Senate respectively, meant to strengthen FDA’s drug enforcement authority.
In July, Rep. Edolphus Towns (D-NY) introduced H.R. 5740 – a bill that would provide FDA with the authority to mandate recalls (IPQ “In the News July 20). Towns had stated his intention to introduce the recall bill during a committee hearing in May that examined Johnson & Johnson’s recall of children’s medicines (IPQ “In the News” June 2).
In early August, Michael Bennet (D-CO) introduced the “Drug Safety and Accountability Act of 2010” into the Senate. The legislation 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 Bennet bill use somewhat different language but are directed at a similar range of objectives to those in the Kennedy bill – primarily providing FDA with monetary penalties and recall tools and requiring drug firms to document the steps in their product ingredient supply chains (IPQ “In the News” August 11).
Providing a springboard for the current legislative efforts were two weeks of hearings held by Congress in April 2008 in the wake of a series of serious health threats from quality breakdowns in the global supply chain, including deaths from tainted heparin sourced from China. The hearings explored the authorities and resources FDA may need to catch up with its health protection mandates and complete its transition into an international regulatory authority.
[Editor’s Note: An in-depth analysis of the 2008 Congressional hearings and of the initiatives the FDA has been putting in place to strengthen its foreign inspection and import programs is provided in the IPQ May/June 2008 Report.]