Trending News Today: FDA Plans to Speed Up Approvals for Gene Therapies

On Tuesday, the House gave the Right to Try legislation final congressional approval by a vote of 250-169, 9 months after it passed in the Senate, the Associated Press reported. According to the article, the measure would give patients diagnosed with life-threatening conditions and who’ve exhausted treatment options access to unproven drugs that have not received FDA approval. The bill also provides some legal protections for pharmaceutical manufacturers, physicians, or others involved in providing the treatment. However, critics say that the measure is weaker in terms of patient protection than the earlier version the House approved in March, the article reported.

New gene therapies will soon get a faster path to approval by the FDA, STAT reported. According to the article, gene therapies for hemophilia specifically could be evaluated based on whether the therapy increases proteins in the blood, regardless of whether the therapy actually causes the patient to bleed less. FDA Commissioner Scott Gottlieb said that hemophilia is the first disease the FDA will target in its new policy, the article reported.

Drug manufacturers called out by the FDA for allegedly stalling generic competition have increased their prices substantially since 2012, costing Medicare and Medicaid nearly $12 billion in 2016, Kaiser Health News reported. The spending totals don’t include rebates, which ranged from 9.5% to 26.3% for Medicare Part D in 2014, the article reported. According to a Kaiser Health News analysis, the cost of Celgene’s Revlimid jumped 40% in 4 years and cost $75,200 per beneficiary in 2016, and cost Medicare Part D $2.7 billion in the same year.