FDA ends Unapproved Drugs Initiative

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The FDA is ending the Unapproved Drugs Initiative, which was created in 2006 to reduce the number of drugs on the market that didn't go through the FDA approval process. 

The agency said the initiative had unintended consequences, such as raising drug costs and creating more shortages. By ending it, the FDA said it believes it will prevent drugmakers from creating monopolies on older drugs and protect Americans from drug price increases and shortages. 

The FDA cited a study from the Yale School of Medicine and University of Utah that found the initiative had caused the average wholesale unit price of  drugs covered by the initiative by 37 percent, and 11 of the 34 drugs studied saw price increases of more than 128 percent. The study also said the initiative rarely generated more clinical evidence of safety or efficacy. 

The initiative increased prices by offering  drugmakers market exclusivity for drugs they took through the regulatory process, allowing them to raise prices with virtually no competition. 

HHS also said it is concerned that the initiative wasn't legally issued because it didn't go through a public comment period before being implemented. 

Before 1938, drugs weren't required by law to be approved by the FDA. When the government passed a law making approval mandatory, many drugs that had been in use for decades and had been proven to be safe and effective were grandfathered in and allowed to be marketed without going through the FDA approval process. 

The FDA created the initiative to get grandfathered drugs through the approval process. The agency also said it wanted to generate more clinical trial data about the drugs. 

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