Draft legislation aimed at overhauling FDA would require more inspections, change user fees

Apr 18 2008

House Energy and Commerce Committee Chair John Dingell (D-Mich.) on Thursday released draft legislation that would make broad regulatory changes to FDA and increase funds for the agency, CQ Today reports.

The legislation -- which takes provisions from several bills, such as (HR 3610), (HR 3624), (HR 3115) and (HR 3484) -- would allow FDA to order the recall of contaminated foods and unsafe medications and medical devices and would establish a group of inspectors to monitor companies that manufacture food, medications, medical devices and cosmetics abroad (Armstrong, CQ Today, 4/17). FDA currently only can request that companies recall products (Freking, AP/San Jose Mercury News, 4/17).

The legislation would establish a new system of fees to finance the additional oversight. Under the system, pharmaceutical, medical device, food and cosmetic companies, both domestic and abroad, would pay an annual registration fee per facility. Importers also would have to register and pay a fee. The legislation also would require facilities that manufacture products regulated by FDA to use an identification number to help the agency track unsafe products back to their manufacturers. In addition, under the legislation, FDA could not close any field laboratories (Edney, CongressDaily, 4/18).

Medications, Medical Devices, Cosmetics

Under the legislation, the HHS secretary would determine the amount of the registration fee for pharmaceutical companies (CQ Today, 4/17). The amount of the registration fee for medical device companies remains undetermined (CongressDaily, 4/18). Under the bill, FDA would inspect all facilities that manufacture medications every two years (Schmit, USA Today, 4/18). Pharmaceutical companies would have to list the country of origin of active ingredients of their medications on labels. Medical device companies also would have to list the country of origin of their products on labels (AP/San Jose Mercury News, 4/17).

In addition, the legislation would require pharmaceutical companies to test their medications for purity. Commercially imported medications or medical devices manufactured at facilities not inspected by FDA would have to enter the U.S. at points with federal facilities with the ability to test their safety and purity (CQ Today, 4/17).

Von Eschenbach Speaks at Conference

In related news, FDA Commissioner Andrew von Eschenbach on Thursday spoke about efforts to improve the agency at a conference at the SAS Institute campus in Cary, N.C., the Raleigh News & Observer reports. Von Eschenbach cited as one of the efforts a switch from paper to electronic systems. He also cited efforts to improve medication safety, reduce the cost of treatments and ensure patient privacy. He also said that FDA "clearly as a role" in regulation of tobacco products but that the agency "does not have the infrastructure in place" or the expertise to fill the role (Vollmer, Raleigh News & Observer, 4/18).