Are Speedy FDA Approvals Jeopardizing Drug Safety?
Public Citizen, a patient advocate group, proposes that since Congress passed legislation to accelerate the approval process for drugs they are more likely to be given safety warnings or pulled from the market.
According to Public Citizen, appropriate time may not be given to study the potential adverse risks before the product(s) are allowed to go to market. The risk is endangering patients by raising the likelihood these drugs may be found dangerous after being taken.
Products cleared before the 1992 Prescription Drug User Fee Act, which sped approvals, had a 21.2 percent chance of eventually being given either a black box warning or being pulled for safety reasons, the study found. Drugs approved after PDUFA had a 26.7 percent chance of receiving the same outcomes, said the study that examined all non-biologic products approved from 1975 through 2009.
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If you believe you may have suffered injury as a result of a dangerous drug or medical device, contact ZK toll-free at (888)841-9623 or visit the firm’s website at www.toledolaw.com. Initial consultations are always free and confidential.