FDA to Allow Generic Companies to Alter Drug Labels

Published Online: Monday, August 5, 2013
Follow Pharmacy_Times:
The FDA intends to allow generic drug manufacturers to update product safety labels to include new information on potential risks, according to a July 4 report in USA Today.

The FDA announcement, made July 3, follows a Supreme Court ruling that struck down a lawsuit involving adverse effects from a generic medication. The 5-4 ruling follows several similar lawsuits, where the court ruled that generic manufacturers were not liable for product safety label updates after a generic is already on the market.

“When it comes to decisions on safety and approval of prescription medicine, the FDA is best equipped to make judgments that affect patients,” said GPhA President and CEO Ralph G. Neas in a release. “The experts at the FDA alone have the scientific knowledge, regulatory experience, and complete data to make these decisions.”

The FDA announcement also follows years of petitions from consumer advocacy groups requesting easier processes for label safety updates, USA Today noted.

Currently, generic manufacturers can only change product labels if the FDA approves of the changes or if the regulatory agency orders them to make changes.

According to USA Today, GPhA would prefer the labeling changes remain under the jurisdiction of the FDA.

“Decisions on safety and efficacy of prescription drugs should rest in the hands of the FDA, the only body with the scientific knowledge, regulatory experience, and complete data that is needed to make these decisions,” Neas told USA Today.

Related Articles
The Generic Pharmaceutical Association welcomes the FDA’s proposed rule to amend its prescription drug and biological product labeling regulations to require electronic distribution of the prescribing information intended for healthcare professionals.
The Generic Pharmaceutical Association has serious concerns about the unbalanced structure of the Trans-Pacific Partnership agreement in its current form.
GPhA has agreed to support compromise automatic substitution legislation that would allow interchangeable biologics to be automatically substituted at the pharmacy. This step brings millions of Americans closer to the day when they will be able to access safe alternatives to costly biologic medicines. Indeed, Express Scripts projects savings of $250 billion in 10 years should only the 11 likeliest biosimilars enter the market.
Today Reps. Doug Collins (R-Ga.) and Dave Loebsack (D-Iowa) introduced H.R. 5815, The Generic Drug Pricing Fairness Act, which creates greater transparency in how pharmacy benefit managers reimburse pharmacies for generic prescription drugs under Medicare Part D, and the Federal Employees Health Benefits Program. The National Community Pharmacists Association endorsed the bill, which goes further than legislation the same two Congressmen introduced earlier year that has the same remedies, but only applied to Medicare Part D.
Latest Issues
$auto_registration$