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WASHINGTON, Sept. 4 /PRNewswire/ via Individual Inc. -- The Seniors Coalition today released the following statement regarding the FDA's recent decision to permit generic competition of Eldepryl(R), a widely prescribed treatment for Parkinson's disease. "The FDA's action has created a significant safety hazard for America's elderly who rely upon this medication," said Thair Phillips, CEO of The Seniors Coalition. "We are normally a strong supporter of generic drug approvals, but have decided to issue an alert to our more than 2 million members and the public so that they are aware that the generic versions of Eldepryl(R) tablets lack the required data to support bioequivalence and therapeutic equivalence of the brand name product." "We feel it is imperative that senior citizens who need this medication be aware of the fact that the generic versions of the brand drug do not, in this case, match the brand drug which is currently being marketed in capsule form," explained Phillips. "The FDA should immediately reverse its decision in allowing the generic versions manufactured as tablets to be marketed. It creates confusion and potentially places patients at substantial risk." The manufacturer of Eldepryl(R) is seeking a preliminary injunction today in Delaware Federal District Court to block further marketing of the tablet form approved for marketing by FDA for three generic companies. Eldepryl(R) was approved by the FDA as an orphan drug in 1989 and is arguably the most effective drug treatment available for end-stage Parkinson's disease patients. "Off-shore foreign black-market suppliers have flooded the American market with unsafe and ineffective copies of this important drug, which forced the manufacturer to switch to a capsule dosage. This new capsule protects consumers from the more confusing tablet version which were easily copied by black-marketeers to appear to be the brand product when they were not," Phillips explained. "The issue for The Seniors Coalition members, and all Parkinson's patients, is that generic drugs should meet the standard applied by FDA for bioequivalence and therapeutic equivalence," Phillips continued. "When generic copies meet this standard, they are given an 'AB' rating. None of the generic copies of Eldepryl(R) have this important rating. Until they do, we believe the confusion in the market puts patients at substantial risk. We believe strongly that unless the FDA rescinds its prior approval of these tablet forms of Eldepryl(R) patients will be subjected to an unacceptable risk for unsafe and ineffective treatment if they use the non-AB rated generic tablets." SOURCE Seniors Coalition /CONTACT: Nona Wegner of the Seniors Coalition, 703-591-0663/ [09-04-96 at 15:02 EDT, PR Newswire]