Under pressure from Congress, the Food and Drug Administration has announced a faster way for patients to apply for experimental drugs for life-threatening conditions.
The agency on Thursday finalized a rule that streamlines the process of applying for compassionate use, which enables a patient to get non-approved treatments when there isn’t any other option. The regulation comes at a time when the FDA is under increasing pressure from Congress and patient groups to soften the agency’s stance on compassionate use.
The agency finalized a new letter that will make it simpler for patients to reduce “the amount of time they spend filling out a request for access to an investigational drug,” Commissioner Robert Califf said in a statement.
The new form should take about 45 minutes to complete, much shorter than the application time patients currently face.
FDA has said it authorizes 99 percent of the compassionate use requests it receives. However, it cannot require the company making the drug to provide it.
FDA recently took heat from Congress to approve a drug eteplirsen to treat Duchenne Muscular Dystrophy, a rare disease that mainly affects young boys.
Two Republican senators wrote to the FDA two weeks ago to approve the drug. They followed a letter from more than 100 House lawmakers in February to also green light it.
The agency has since delayed a decision on eteplirsen.
