In the current regulatory environment, exemptions to the three-trial rule are occasionally permitted under decades-old rules, and the criteria used are termed by the industry as “unclear and unpredictable.” Accelerated approval allows the shorter trials to prove a measured effect of a trial therapy, in place of a clinical outcome. After the fact, the drug company must prove that the drug is effective. Physicians may also assist patients in gaining access to medications that they feel will benefit a patient.

 

The legislation provides that if a drug were approved for use in other countries, this would carry significant weight in approving drugs quickly in the United States. In addition, the draft legislation addresses a possible overhaul of the fee system pharmaceutical companies use to fund FDA reviews. Discussions between the FDA and the drug industry have leaned toward a 6-percent fee increase as part of a plan that extends to 2017.  

 

The legislation would also enable the creation of an internal management review board at the FDA, which would be intended to increase the efficiency of the agency. Twenty-two individuals would be appointed to the board, with some members coming from within the agency. The biotech, drug, food and medical device industries would also be represented. The appointment of a chief innovation officer would also become a reality if TREAT becomes law. It would also set in stone the term of the FDA commissioner at six years, but not limit reappointments of that individual to additional terms.  

 

Hagan’s office and BIO representatives did not return calls for comment for this story.