October 18, 2000
The Honorable Jane E. Henney, M.D. Dear Commissioner Henney: On October 3, 2000, you testified before the Subcommittee on Oversight and Investigations regarding a number of issues pertaining to your agency’s oversight and regulation of pharmaceuticals sent to the United States from foreign sources. Because the Food and Drug Administration (FDA) is unable to keep pace with its current mandate of regulating foreign drug manufacturers shipping to the U.S., and because your agency remains underfunded in key areas of post-market surveillance, I expressed strong concerns about proposals allowing for the reimportation of prescription drugs from abroad. As I mentioned at that hearing, I believe drug prices are excessive for many low-income Americans, and that Congress and the Administration must explore ways to lower these costs. But I am troubled that the reimportation provisions inserted into the Agriculture Appropriations Conference Report passed by the House last week attempt to solve this problem at the cost of safety. Simply put, I believe that this well-intentioned undertaking has placed FDA’s "gold standard" at considerable risk. Worse still, drug prices may not even be significantly lowered by these plans. There is nothing that guarantees that, in the process of undermining our current regulatory system, prices will fall. The provisions make long-term changes to the Food, Drug, and Cosmetic Act, without benefit of hearings before an authorizing committee. Also, I remain particularly troubled that the FDA, which continues to be underfunded and thus unable to cover its present regulatory mandate, is about to become inundated with greater responsibilities, but with no guarantee of long-term funding. Even if Congress were to provide the additional resources, I remain skeptical that FDA could even construct a global regulatory framework as safe as what we now have. FDA was unsuccessful in preventing counterfeit and substandard drugs from entering the U.S. before the Prescription Drug Marketing Act (PDMA) went into effect, and so I doubt it will be successful once many of that Act’s protections are undermined by this legislation. Given my ongoing concerns regarding this matter, and a need to complete the record for the October 3 hearing, I would like you to provide me with answers to the questions in Attachment A. I look forward to your reply no later than Thursday, November 2, 2000. Should you have any questions regarding this matter, please call me, or have your staff contact Christopher Knauer, Minority Investigator, at 202-226-3400. Sincerely, JOHN D. DINGELL cc: The Honorable Tom Bliley, Chairman
| |
|
 |
 |
 |
 |
 |
 |
 |
 |
