H.R. 1483, the Drug Safety Enhancement Act, would solve many of the problems FDA is facing

Washington, D.C. – Today, U.S. Congressman John D. Dingell (D-MI15) issued the statement below at the House Energy and Commerce Subcommittee on Health hearing entitled: “PDUFA V: Medical Innovation, Jobs, and Patients.”  The Prescription Drug User Fee Act (PDUFA) was enacted in 1992 and renewed in 1997, 2002, and 2007.   PDUFA will be up again for reauthorization next year.  PDUFA authorizes FDA to collect fees from companies that produce certain human drug and biological products.  Since its passage, user fees have played an important role in expediting the drug approval process.  In today’s hearing Mr. Dingell asked questions that conspicuously pointed out the FDA desperately needs the funding and additional authorities in H.R. 1483:

“Thank you Mr. Chairman for holding today’s hearing.  The reauthorization of PDUFA offers the opportunity for this Committee to improve on the drug safety provisions included in the FDA Amendments Act of 2007.  We must start by giving FDA the authority it needs to meet its responsibility to ensure quality and safety of an increasingly globalized drug supply.  Common sense authorities like mandatory recall, subpoena power, ability to seize and destroy imported drugs at the border that pose a health threat, making the delay or refusal of an inspection a prohibited act are needed now to improve FDA’s capabilities to oversee our drug supply.  These are all authorities that would be given to the FDA under H.R. 1483, the drug safety bill I introduced with my colleagues Mr. Waxman, Mr. Pallone and Ms. DeGette.

“These authorities will only be of use to the FDA though if Congress provides the necessary funding.  It is wholly irresponsible for Congress to delegate new authority to the FDA without funding to implement it.  And unfortunately, this is the perfect storm that we are now witnessing with the food safety law.  Americans have come to expect that their prescription drugs will improve health and prolong life expectancy, not cause harm or death.  The FDA has a duty to the American public to ensure the safety of the Nation’s drug supply, and I hope that my colleagues will work with me to give the FDA the authority needed to meet this duty.”

To view Congressman Dingell questioning the Dr. Janet Woodcock on Panel 1, click here:

http://www.youtube.com/watch?v=a7A75x8__uE

To view Congressman Dingell questioning the Mr. Allan Coukell on Panel 2, click here:

http://www.youtube.com/watch?v=CDUFdiwFA50