Drug Safety :: AARP praises drug safety, generic drug market access provisions of FDA Bill

AARP hailed the Senate passage of two provisions that would improve drug safety and improve generic drug market access. The provisions were part of a Food and Drug Administration (FDA) bill that reauthorizes the prescription drug user fee programs at FDA, known as the Prescription Drug User Fee Amendments of 2007 ? or, PDUFA ? (S. 1082).

“This bill is a good start towards safer drugs and lower prices, but much remains to be done,” said AARP Director of Government Affairs David Sloane. “There is no one solution to the problem of high drug prices. It is a series of steps ? and this bill makes a few of them. Allowing the FDA to approve generic versions of biologic therapies would be another, and allowing for the safe and legal importation of drugs from abroad would bring us even closer to our goal. It is critical that Congress continue to work to solve this serious problem. As this bill goes to the House, AARP will be working to ensure that wherever possible we are working to make drugs safer and more affordable.”

The amendment offered by Senators Byron Dorgan (D-ND) and Olympia Snowe (R-ME) phases in requirements that prescription drugs sold in the U.S. conform to anti-counterfeiting measures such as labeling and packaging. The amendment offered by Trent Lott (R-MS) and Debbie Stabenow (D-MI) closes a loophole that allows brand name drug companies to use the current FDA rules for challenging brand name drug patents as a delaying tactic against the introduction of lower cost generics. AARP supports both these amendments.

Finally, the underlying FDA bill includes language calling on the Senate Health, Education Labor and Pensions Committee to approve legislation providing a pathway within FDA to approve lower-cost generic versions of biologic therapies. That markup is scheduled sometime in the next month.

“Ensuring the safety of our drug supply and eliminating hurdles from bringing lower-cost generic drugs to the market are significant improvements to our health care system,” continued Sloane. “It is critical that Americans can trust that the name on the outside of the pill bottle accurately represents the pill that?s in the bottle. The anti-counterfeiting measure that passed today brings us closer toward that end.

“Further, by eliminating unnecessary hurdles that keep lower-cost generic drugs from the market, we are one more step down the path towards affordable prescription drugs. Generic drugs make up more than half of all prescriptions dispensed in the U.S. and for good reason: many people cannot afford the high cost of brand name drugs. AARP is pleased that the Senate bill includes provisions to help prevent the pharmaceutical industry from using tactics to delay market entry of lower-priced generic drugs,” Sloane concluded.

AARP is a nonprofit, nonpartisan membership organization that helps people 50+ have independence, choice and control in ways that are beneficial and affordable to them and society as a whole. We produce AARP The Magazine, published bimonthly; AARP Bulletin, our monthly newspaper; AARP Segunda Juventud, our bimonthly magazine in Spanish and English; NRTA Live & Learn, our quarterly newsletter for 50+ educators; and our website, AARP.org. AARP Foundation is an affiliated charity that provides security, protection, and empowerment to older persons in need with support from thousands of volunteers, donors, and sponsors. We have staffed offices in all 50 states, the District of Columbia, Puerto Rico, and the U.S. Virgin Islands.


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