Sanders, Cummings Urge Department Of Justice To Launch Criminal Investigation Into Generic Drugmakers’ Prices

Stat: Sanders And Cummings, Citing ‘Polite F-U Letters,’ Urge Feds To Step Up Probes Of Generic Makers
As dozens of states pursue numerous generic drug makers for price-fixing, a pair of prominent lawmakers have complained to the Justice Department about a “lack of enforcement” and asked the agency to accelerate its own investigation into the companies. In a letter sent to the feds on Wednesday, Sen. Bernie Sanders (I-Vt.) and Rep. Elijah Cummings (D-Md.) also asked the Justice Department to probe whether 14 generic drug makers obstructed their own 2014 investigation into “suspicious” price increases for several generic medicines. (Silverman, 6/13)

CNN: Lawmakers Urge DOJ To Launch A Criminal Probe Of Generic Drug Makers
"We urge the Department of Justice to investigate whether generic drug companies and executives violated criminal antitrust laws and ask that the Department of Justice pursue enforcement if warranted," the lawmakers said. The news comes on the heels of a lawsuit filed last month by a coalition of 44 states, alleging that 20 major drug manufacturers conspired to artificially inflate and manipulate the prices of more than 100 generic drugs, with the companies making billions in the process. (Drash, 6/13)

Stat: How A Mishap At A Photocopier Derailed Clinical Trials And A Development Deal
Sometimes, small mistakes become big problems. Just ask Ferring Pharmaceuticals. Several years ago, an employee inadvertently switched dosage labels that were printed on a photocopier, triggering a series of events that undermined a pair of late-stage clinical trials and ultimately scrapped a development deal, according to a lawsuit filed by Elobix, its erstwhile partner. (Silverman, 6/13)

Stat: ‘It Felt Like An ’80s Criminal Drama’: What Happened When A Biohacker Met Bureaucrats Investigating Him
A few weeks ago, the prominent biohacker Josiah Zayner took to Instagram to break some news: He had received a letter from the California Department of Consumer Affairs saying that officials were investigating him. The reason? A complaint had been made alleging that he had been practicing medicine without a license. Zayner runs the ODIN, a company here that sells equipment for do-it-yourself science, including a $159 DIY CRISPR kit. He got his own biotech training the conventional way — he has a Ph.D. in biochemistry and biophysics from the University of Chicago — but he’s since become a leader in the biohacking community. (Robbins and Feuerstein, 6/14)

Stat: Global Blood's Sickle Cell Disease Drug Heads To FDA, As Questions Linger
Global Blood Therapeutics (GBT) said Friday that its once-a-day pill for sickle cell disease boosted levels of oxygen-carrying hemoglobin in a little more than half of the patients treated in a Phase 3 clinical trial — results that will allow the company to file soon for accelerated approval for the treatment in the U.S. Some outside experts, however, cautioned that it’s far from certain whether the results will translate into better health outcomes for patients themselves, even if the clinical trial achieved its main goal. (Feuerstein, 6/14)

Modern Healthcare: Washington Wins CMS Approval For Hepatitis C Drug Subscription Deals
Washington became the fourth state to win a Medicaid state plan amendment allowing it to negotiate value-based purchasing agreements with prescription drug manufacturers. The CMS announced Wednesday that it approved Washington's proposal to let the state negotiate under a subscription model with makers of costly hepatitis C drugs. Under that model, the state would pay a fixed annual amount to a manufacturer to buy an unrestricted supply of hepatitis C drugs. (Meyer, 6/13)