Prioritizing generics — 4 strategies for lower drug costs from Dr. Scott Gottlieb

Food and Drug Administration Commissioner Scott Gottlieb, MD, outlined his strategy to lower drug prices during a Monday interview with Bloomberg.

Here are four ways Dr. Gottlieb seeks to address high drug costs.

1. Increase generic competition. Dr. Gottlieb told Bloomberg the FDA is exploring how to prioritize the review of applications for drugs with fewer than three competing generic versions on the market. He believes adding more generic competition will lower prices, according to the report.

"We know the most significant savings to consumers comes when there are three generics on the market," Dr. Gottlieb told Bloomberg.

2. Eliminate FDA backlog. The FDA is considering a plan to clear a backlog of 2,640 generic-drug applications within a year, according to Dr. Gottlieb.

3. Ensure distribution of brand name drugs for generic companies. The FDA is brainstorming ways to prevent brand name drugmakers from restricting access to their medications. Without access to the brand name drug, generic companies cannot test their product for clinical equivalence and earn FDA approval.

"Getting access to 3,000 tablets can be hard unless the branded companies are going to facilitate the ability of the generic companies to get the drug," Dr. Gottlieb told Bloomberg. "They can't just go into the market and buy it readily."

4. Emphasize brand name drugs with no generic competition. Dr. Gottlieb said the agency is also exploring the publication of a list containing 180 brand name medications — no longer under patent protection — that still don't have any generic competitors, according to Bloomberg. The FDA has never received a new drug application from a generic drugmaker for 150 of the 180 brand name drugs on the list.

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