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Talk of bringing down the price of pharmaceuticals often hinges on generic competition, and the US is seeing approvals of new generic drugs faster and more consistently than ever – a trend likely to continue...The progress comes as Food and Drug Administration Commissioner Scott Gottlieb...indicated that the agency will expand which abbreviated new drug applications will see priority reviews..."Earlier this year we made changes to how we prioritize the agency’s generic drug submissions. The goal was to prioritize the review of generic applications until the FDA has approved three generic versions of each particular drug," Gottlieb said in a statement. "Today we’re expanding this competition-focused policy to prioritize any application that can meet the FDA’s approval standards at the point when the 180-day exclusivity period expires on a first generic entrant to a branded medicine."...The shift could accelerate generic competitors to market more quickly and help bring down costs, and comes a day after the Federal Trade Commission held a workshop on drug competition.

The U.S. Food and Drug Administration said...it will allow regulators in eight European countries to determine whether drug manufacturing facilities there meet FDA requirements, freeing up American inspectors to spend more time in higher-risk countries like India and China...The FDA said it will begin relying on inspection data from the regulators in Austria, Croatia, France, Italy, Malta, Spain, Sweden and the United Kingdom as of Nov. 1...in some situations the United States could still do inspections in those countries...The move is the first step by the FDA to implement an agreement the United States and the EU finalized in March. The European Commission already determined in June that the FDA could carry out inspections for it in the United States...FDA Commissioner Scott Gottlieb said in a statement that partnering with European regulators would allow the agencies to get “the greatest bang for our collective inspectional buck.”

The U.S. Food and Drug Administration plans to encourage widespread use among opioid addicts of less harmful opioid drugs such as methadone and buprenorphine, a radical shift in policy that could draw opposition from those in the addiction field who believe abstinence is the only effective treatment...FDA Commissioner Scott Gottlieb outlined a proposal under which every addict who suffers a non-fatal overdose would be treated with an opioid substitute, for long periods if necessary, or even for life...“I know this may make some people uncomfortable,” Gottlieb said...“FDA will join efforts to break the stigma associated with medications used for addiction treatment.”...The FDA, Gottlieb said, will issue guidance for drugmakers to promote the development of new addiction treatments and lay out the agency’s interest in “novel, non-abstinence-based” products...