Senate Bill Introduced to Increase FDA Authority

Aug 12, 2010   

August 5, 2010

This week Sen. Michael Bennet (D-CO) introduced the Drug Safety and Accountability Act of 2010 to the U.S. Senate. The Bill aims to increase the authority of the U.S Food and Drug Administration (FDA) to regulate drugs manufactured overseas and allow for heightened oversight and regulation of over-the-counter (OTC) drugs.

Bennets Press Release explains, “For too long, the FDA has lacked the proper authority to adequately safeguard our drug supply and protect Colorado consumers. Its time Washington took acting to ensure the medicines Coloradans rely on are safe, and that those entrusted with the responsibility of developing these drugs are equipped to keep consumers out of harms way.”

The Bill was introduced the same day the Pew Prescription Project released poll results indicating that nine in ten voters support new safety measures for prescription drugs. The report also revealed that U.S. consumers have low confidence in the safety of drugs manufactured abroad, especially those produced in China and India.

The FDA has indicated support for the reforms, with Principal Deputy Commissioner Joshua Shafterstein stating that he believes the FDA needs authority to issue mandatory drug recalls. Additionally, The Pew Prescription, AARP, American College of Physicians, Consumers Union, Society of Chemical Manufacturers and Affiliates, the Community Catalyst, and others have issued a joint letter to Congress in support of the Bill. Proponents of the Bill estimate that 80% of active ingredients in U.S. pharmaceuticals are made abroad. Proponents, including the Bills sponsor, also note the 1,742 drug recalls implemented in 2009, which represents a 400 percent increase over 2008.

The new Bill would provide the FDA with additional recall power and enforcement options along with better tools to look into possible drug quality and safety issues including:
¢ Authority to assess civil penalties for Food, Drug and Cosmetic Act violations.
¢ Authority to subpoena documents and witnesses.
¢ Increased ability to exchange information between the FDA and other regulatory agencies.
¢ Ability to protect industry whistleblowers who bring information to the FDA.

The Bill would also increase manufacturer standards by:
¢ Requiring Companies to institute quality management plans to insure quality and safety of their drug components.
¢ Requiring companies to increase supplier oversight and document entities involved in supply chain for drug manufacturing

Finally, the Bill aims to increase oversight of over-the-counter medications by re-assigning them from a lower-risk category for inspection.

This Senate Bill comes only two weeks after House Representative Ed Towns (D-NY), Chair of Committee on Government Oversight and Reform, introduced the FDA Mandatory Recall Bill, also intended to increase FDA power. The House Bill, introduced July 15, would allow for the FDA to implement a quicker and more thorough recall process than the voluntary recall process currently in place. If the House Bill passes, the FDA will have the ability to order mandatory recalls for adulterated or misbranded drugs or drugs which pose a considerable risk of death or serious health consequences. The Bill was referred to the House Committee on Energy & Commerce.

The House Bill was introduced the same day Johnson & Johnson submitted a plan to correct problems at a Tylenol plant. The plan was required by the FDA after an April 30th cite check found numerous violations of good manufacturing conditions. The cite check coincided with recalls issued for Benadryl, Motrin, Tylenol, and Zyrtec for infants and children because of possible metallic particle contamination. The plan included new equipment and operations procedures.

For more information regarding current FDA authority, procedure, or regulations please contact us at contact@fidjlaw.com.