Senate bill seeks to stop excessive drug price hikes

Legislation that would allow HHS to stop unjustifiable drug price hikes has been introduced by Sen. Richard Blumenthal, D-Conn., and three other Senate Democrats. The CURE High Drug Prices Act will permit HHS to force pharmaceutical firms to pay back unjustifiable increases in drug prices to payers and other consumers if the agency deems a price hike is excessive or to bring back the drug's old price for a certain period under qualified or federal health plans. BioCentury (12/13)

FDA withdraws generic-drug labeling proposal

The FDA withdrew a proposed rule that would have required generic-drug makers to monitor patient safety and update labels with new safety data regardless of updates to the reference product's label. Some stakeholders had expressed concern that the rule could have undermined public confidence in generics and led to higher prices and confusion among patients and physicians. Regulatory Focus (12/13)

Senator seeks ideas from insurers, others on reducing health costs

Sen. Lamar Alexander, R-Tenn., this week asked insurers, hospitals and other stakeholders to submit ideas on reducing health care costs by March 1, 2019. Alexander, chairman of the Committee on Health, Education, Labor, and Pensions, said he plans to have the committee work on legislation next year to reduce health care costs. Modern Healthcare (tiered subscription model) (12/11)

BIO calls on drugmakers to stop taking price hikes

Biotechnology Innovation Organization Chair John Maraganore urged drugmakers to pledge to not increase drug prices. Maraganore, who is also CEO of Alnylam Pharmaceuticals, said that "[T]he industry can do better, and Alnylam has stood uniquely to look at things like drug price increases and say 'no, we aren't going to do drug price increases." BioPharma Dive (12/13)

Patent appeals board: Mylan didn't infringe Sanofi's Lantus patents

The US Patent Trial and Appeal Board rejected Sanofi's claims that Mylan infringed patents on Lantus long-acting insulin, but a Sanofi spokesman said the decision is unlikely to change the market entry time of Mylan's competing product. Reuters (12/13)

Catalyst Pharma sets sky-high price on new version of old drug

Catalyst Pharmaceuticals plans to set a list price of $375,000 a year on Firdapse, which the FDA approved last month to treat Lambert-Eaton myasthenic syndrome. The drug has been available for years at a few hundred dollars per month through compounding pharmacies. STAT (tiered subscription model) (12/13)

You will do foolish things, but do them with enthusiasm.

Sidonie-Gabrielle Colette, writer and actress