Bills to Watch
Congress Probes FDA’s Review of Allegedly Unsafe Medical Devices
A number of top managers at the Food and Drug Administration have been accused by several current and former colleagues of corrupting and interfering with scientific reviews of medical devices which caused two Members of a key Congressional Committee to call for an investigation. The House Energy and Commerce Committee will review ``compelling evidence'' contained in a letter from the current and former FDA employees that devices were approved in violation of laws to ensure their safety according to a statement
The letter alleged that managers ``ordered, intimidated and coerced FDA experts to modify their scientific reviews, conclusions and recommendations'' on devices according to a statement from Committee Chairman Rep. John Dingell (D-MI) and Investigations Subcommittee Chairman Rep. Bart Stupak (D-MI) in a statement. The lawmakers posted a redacted image of the letter on its website in order to detail the allegations while protecting the identities of the would-be whistleblowers. ``These allegations are deeply concerning, and we intend to uncover whether any FDA activity has compromised the health and safety of American consumers,'' said Rep. Dingell in the statement.
FDA Opens Chinese Offices for its Foreign Drug Inspection Program
On November 19, the Food and Drug Administration (FDA) opened three offices in the People’s Republic of China to ensure the safety of food and medical products exported from that nation to America. FDA will initially have at least eight American employees, in addition to Chinese hires, in Beijing to certify inspections of U.S.-bound Chinese exports. "By having a presence in other parts of the world, we can work more closely with manufacturers and other governments, better share best practices and further ensure that quality and safety are built into food and consumer products at the point of manufacture,” Health and Human Services (HHS) Secretary Michael Leavitt said at a news conference.
Recent problems with tainted products from foreign makers have spurred interest in the establishment of these types of offices in major exporter nations. The goal of this project is allow FDA to work more closely with their Chinese counterparts in setting quality standards and to educate companies and their distributors. Next year, FDA will place additional staff in the offices in the cities of Shanghai and Guangzhou. FDA plans on establishing a permanent presence in five geographic regions around the globe including China, India, Europe, Latin America and the Middle East. HHS & FDA are currently in the process of pursuing the Indian government’s formal approval for establishing its second overseas office in the Republic of India. More information on the inspection program can be found at the FDA’s Office of International Programs and HHS’ own independent website entitled importsafety.gov.
WSJ: Critics Lead List of Possible New FDA Commissioners
A list of several leading candidates to be the next Commissioner of the Food and Drug Administration includes the names of several critics of the agency according to a story in the Wall Street Journal on December 12. The leading candidate mentioned in the article is Joshua Sharfstein who currently serves as health commissioner of Baltimore, Maryland. Dr. Sharfstein is a Harvard Medical School-educated pediatrician who has also served as a Congressional investigator for incoming House Energy & Commerce Chairman Rep. Henry Waxman (D-CA). He also serves on the Obama transition committee team which is reviewing the FDA which may give him an inside track on the position. A review of his past articles show support for FDA regulation of tobacco, ethical concerns about drug company events for doctors to push specific drugs, and questions about pediatric prescriptions.
Another name reportedly under consideration for the position include Cleveland Clinic cardiologist Steve Nissen. Dr. Nissen has also been critical of FDA’s actions on medicine approval, arguing that too many drugs are put on a fast track for approval when companies say they are life savers even if they are not. The article states that in a recent speech, Dr. Nissen said that FDA should require companies to prove their drugs save lives. The article also mentions other possible nominees including Duke University’s Robert Califf, food and drug lawyer Frank Sasinowski, and Janet Woodcock, the current head of FDA’s drug center.