The Food and Drug Administration will force pharmaceutical companies to get their drugs off the market once and for all, a senior FDA official said Monday.
The move is the latest step in the agency’s long-running battle against fraud and misbranding, and comes amid rising concerns about drug safety.
Under the new rule, manufacturers would have to get FDA approval to make a drug with a generic name or to market a new version of the drug under a brand name, which is required to comply with a 2011 law that gives the agency authority to investigate and seize drug makers’ assets if it suspects fraud.
The agency has seized more than $1 billion in assets from drugmakers since it was established in 1935.
The new rule requires drugmakers to get approval before they can market a generic version of a drug under their own brand.
The FDA’s decision follows a year-long investigation by the agency that identified dozens of pharmaceuticals that could have violated the law.
The agency said the new law would also help combat fraud by limiting the scope of the agency to cases in which a drug is not manufactured in a facility that has been identified as a manufacturing site for fraud or for other violations.
The FDA will be able to investigate more of those cases, it said.
Drugmakers and other drugmakers say the new rules will force them to do more to ensure that drugs are safe and effective.
“We believe these new rules should be viewed as an additional check on companies that are committing fraud, not a replacement for the existing FDA oversight framework,” said Paul K. Blumberg, the FDA’s assistant administrator for enforcement and enforcement.
Some of the companies have already been subject to FDA inspections for manufacturing in a manufacturing facility that failed to meet standards.
They include Pfizer, Valeant Pharmaceuticals, AstraZeneca and Johnson & Johnson.
But the FDA has said the rules are necessary to ensure safety of the drugs.
The rules require companies to test the drugs for ingredients, make sure the drugs are manufactured to FDA specifications and comply with quality standards.