Unbiased Analysis of Today's Healthcare Issues

User Fees: A solution to decrease wait times for FDA approval of generic drugs?

Written By: Jason Shafrin - Oct• 21•10

The Consumer’s Union used Medicare.gov to show that many people could save $3,500-$5,000 by switching to generics.  Why don’t more people do so?  One reason is the long delays for FDA approval of generics.  The FDA’s Office of Generic Drugs is understaffed and thus generic drug approvals takes much longer than it should.

Brand name pharmaceuticals pay user fees to the FDA to speed up approval time.  Is this a good idea to apply for generics as well?

A Consumer Reports (Nov 2010) editorial states the following:

In general, we oppose user fees that allow a regulated industry to fund the regulators.  A government agency can become dependent on the companies it’s supposed to objectively regulate , which can influence decision. In a 2006 survey…many FDA employees said they felt pressured to hastily and perhaps improperly approve user-fee drugs.  And at least one felt the agency viewed industry, not the American public, as its client.

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3 Comments

  1. jamzo says:

    the ubiquitous “pay to play” argument

  2. BillG says:

    You would think there would be funds available for anything that would speed the process as long as it could be done in a safe way.

  3. [...] Jason Shafrin: Brand name pharmaceuticals pay user fees to the FDA to speed up approval time.  Why not let generics do the same? [...]

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