The current reauthorization process offers an opportunity to correct these negative trends while adding transparency and efficiency back into the process.
But consumer groups are pushing to add even more requirements in the latest version of PDUFA. They want Congress to mandate, for example, that drug companies undertake “comparative effectiveness” studies prior to the approval of a new drug. That would add many months and tens or even hundreds of millions of dollars to the cost of bringing a new drug to market, expenses that would add to the cost of new drugs.
A regulatory model that provides drug companies with transparency, clarity and certainty is essential to innovation. Congressional reauthorization of a clean PDUFA bill will ensure that lifesaving medicines get to the patients who need them in a timely manner. Other issues can wait for a more thorough and focused debate.
Grace-Marie Turner is president of the Galen Institute.