FDA eases rules on drug manufacturing

	Tweet

Drug makers will not need regulatory approval for every change in their manufacturing processes under new guidelines designed to prevent supply disruptions, U.S. health officials said on Wednesday.

Companies can skip the prior approval requirement if they have developed adequate tests and procedures to show certain changes will not affect product safety or effectiveness, the Food and Drug Administration said in a report. 

The modification is part of a just-completed, two-year effort to overhaul regulation of pharmaceutical manufacturing, a major issue for drug makers.

In the past, Schering-Plough Corp., Eli Lilly and Co. and other companies had trouble meeting federal production standards and faced delays in the approval of new medicines.

Some critics said the changes amounted to decreased regulation that could harm patients if problems were not uncovered before medicines were released to the public.

“I don’t think it’s a good idea. From a patient perspective, it is questionable and intermittently dangerous,” said Dr. Sidney Wolfe, head of Public Citizen’s Health Research Group, a consumer group.

Health and Human Services Secretary Tommy Thompson, in a statement, said the FDA’s plan would ensure “consistently high quality” for the U.S. drug supply.

The FDA said the new measures would help drugs get on the market quicker and prevent supply shortages or disruptions. The agency also wants to encourage companies to adopt new technologies.

“In the past, as a result of the many uncertainties in drug manufacturing, the FDA exercised extensive control over virtually every aspect of the manufacturing process,” the FDA report said.

“Consequently, pharmaceutical companies have often been reluctant to change their manufacturing processes and equipment because of perceived, and sometimes real, regulatory hurdles.”

The new system will focus inspections on plants that produce medicines with the most potential to harm patients if quality control lapses occur. Companies with effective quality control systems in place will be subject to fewer and less extensive inspections, the FDA said. 

RELATED STORIES:
Study: Plavix saves lives after big heart attacks   The first and only fusion inhibitor for the treatment of HIV   Powerful pain medicine a growing U.S. crime problem   UK scientists develop new vaccine technology   Bristol-Myers Squibb and Otsuka Pharmaceutical announce availability of 2 mg Abilify (aripiprazole)   Roche to supply Tamiflu raw ingredient to Vietnam   FDA warns Chiron over flu vaccine plant   Prozac Use Weakens, Shrinks Young Bones   FDA Advisers Vote Against Female Sex Drug   Illegal drug trade a world force   Separate profit from research, agency advises   ‘Statin’ drugs lower blood pressure somewhat

Comments

[ + Post Your Own ]

Now you're in the public comment zone. What follows is not Armenian Medical Network's stuff; it comes from other people and we don't vouch for it. A reminder: By using this Web site you agree to accept our Terms of Service. Click here to read the Rules of Engagement.

There are no comments for this entry yet. [ + Comment here + ]