FDA received the authority to mandate recalls of food under a new food-safety bill. Efforts are underway in the US House of Representatives to grant the agency this power for pharmaceuticals as well.
Congress passed the FDA Food Safety Modernization Act on Dec. 21, 2010, and President Obama signed the bill on Jan. 4, 2011. The Act revamps FDA’s authority over food safety and includes the following key points:
- It allows FDA to establish and enforce a prevention-based approach to food safety, requiring food facilities to keep a written plan of possible problems and solutions.
- FDA gains the ability to hold food companies accountable for preventing contamination.
- It outlines a risk-based approach to inspections of food-processing facilities, as well as increasing the frequency of inspections.
- It strengthens the safety of imported foods by giving FDA more authority over importers and enforcement of food-safety requirements.
- Finally, it gives FDA the authority to issue mandatory recalls. The agency said in a statement, “While FDA expects that it will only need to invoke this authority infrequently since the food industry is largely compliant with FDA’s requests for voluntary recalls, this new authority is a critical improvement in FDA’s ability to protect the public health.”
FDA Commissioner Margaret A. Hamburg issued a statement on Dec. 21 supporting the legislation, saying, “This law makes everyone responsible and accountable at each step in today's global food supply chain.” The commissioner also posted on Jan. 3, 2011, on The White House Blog and foodsafety.gov about the importance of prevention to the safety of the nation's food supply and highlighted those aspects of the legislation.
Drugs could be next
A bill was introduced in the House on Dec. 17, 2010, that focuses on expanding FDA’s authority and providing it with the proper resources to ensure the safety of pharmaceutical products. Reps. John D. Dingell, chairman emeritus of the Energy and Commerce Committee; Henry A. Waxman, chairman of the Energy and Commerce Committee; Frank Pallone, chairman of the Subcommittee on Health; and Bart Stupak, chairman of the Subcommittee on Oversight and Investigations, introduced H.R. 6543, The Drug Safety Enhancement Act. Among the provisions of the bill is the power to enforce mandatory recalls.
The topic of granting FDA this authority was recently discussed during the second Congressional hearing on Johnson & Johnson’s recalls. FDA Deputy Commissioner Joshua Sharfstein said during his testimony to the The House Committee on Oversight and Government Reform that there is a need to rethink the current system of voluntary recalls and that the agency should have the ability to initiate drug recalls. A poll conducted on PharmTech.com in June showed that 72% of readers think FDA should have this authority. Perhaps now that the agency is close to gaining the power to recall food, increased pressure will force lawmakers to reconsider expanding that authority to pharmaceuticals as well.
As stated on Rep. John D. Dingell’s website, H.R. 6543 also:
- "Creates an up-to-date registry of all drug facilities—both foreign and domestic—serving American consumers
- Generates funding for increased Good Manufacturing Practices (GMP) inspections for brand and generic drugs
- Requires parity between foreign and domestic inspections
- Prohibits entry of drugs coming from domestic and foreign facilities that limit, delay or deny FDA inspections
- Prohibits the entry of drugs into the US lacking documentation of safety
- Requires manufacturers to know their supply chain, identify and mitigate risk throughout their supply chain, and to document measures taken to secure their supply chain
- Prohibits false or misleading reports to FDA
- Provides strong new enforcement tools, including mandatory recall authority, increased civil and criminal penalties, and new FDA authority to subpoena records related to possible violations
- Provides protection for whistleblowers that bring attention to important safety information
- Requires unique identification numbers for drug establishments and importers to improve the ability of the FDA to more quickly identify parties involved in a crisis situation."
After introduction last month, the bill was referred to the House Committee on Energy and Commerce.
This article was originally published as a blog post on PharmTech Talk on Dec. 30, 2010.