What We're Reading: "Right-to-Try" Law Set; FDA to Speed Gene Therapies; Drug Pricing Analysis Finds Increases

The “right-to-try” bill heads to President Trump’s desk for signing after passing the House of Representatives; the FDA said certain gene therapies in development can qualify for quicker review, starting with hemophilia; brand-name drug makers have raised prices by double-digit percentages since 2012, with 47 drugs costing Medicare and Medicaid nearly $12 billion in 2016.

"Right-to-Try" Bill Headed for Trump's Signature

FDA Clears Quicker Path for Some Gene Therapies

The “right-to-try” bill heads to President Trump’s desk for signing after passing the House of Representatives for the second time by 250-169. The bill, which would allow terminally ill patients to bypass the FDA and request experimental drugs that have cleared phase 1 safety trials directly from drug companies, passed largely along party lines. The Senate passed the bill in August 2017, and the House approved its own version in March. That version was opposed less by medical groups, but then the legislation stalled. House leaders decided to pass the Senate version instead, The Washington Post reported.The FDA said certain gene therapies in development can qualify for quicker review, STAT reported. Commissioner Scott Gottlieb, MD, said that hemophilia is the first disease the FDA will target with its new policy. Under the new policy, gene therapies for hemophilia could be evaluated based on whether the therapy increases clotting proteins in the blood, regardless of whether the therapy actually causes the patient to bleed less.

Brand-Name Pharmaceuticals Had Double-Digit Price Hikes Over 4 Years

Brand-name drug makers blamed by the Trump administration for potentially stalling generic competition have raised prices by double-digit percentages since 2012, with 47 drugs costing Medicare and Medicaid nearly $12 billion in 2016, Kaiser Health News reported. Kaiser’s analysis said the spending totals don’t include rebates, which pharmaceutical companies return to the government. The rebates ranged from 9.5% to 26.3% for Medicare Part D in 2014.