Congressional Proposal To Streamline FDA Approvals Worries Consumer Advocates
As the House moves forward with the "21st Century Cures" bill, some warn that its provision allowing “clinical experience" over randomized controlled trials could lead to lower standards when approving new uses for existing drugs. Other outlets report on more pharma news, including lessons learned from an international drug pricing study and examples of insurers and drug companies teaming up to reduce sticker shock on new speciality drugs.
The Wall Street Journal:
Speeding Up Drug-Approval Process Could Have Downside
Would a congressional bill designed to jump-start medical innovation end up lowering standards for approving new uses of existing medicines? Consumer advocates are raising this concern about the 21st Century Cures legislation, which passed the House Energy and Commerce Committee unanimously last week and, in part, is designed to reform the approval process for drugs. Supporters say the bill is a long overdue move that, among other things, will give the FDA the tools to ensure treatments reach patients faster. (Silverman, 5/28)
California Healthline:
New Study Offers Drug Pricing Lessons From Abroad, Urges Changes In U.S.
A new study that compares drug prices in four countries finds that "pharmaceutical prices in the United States are extraordinarily high and have contributed to an unsustainable level of spending on drugs." (Lauer, 5/28)
Bloomberg:
Big Pharma And Insurers Play Nice
In the summer of 2014, biotechnology company Amgen seemed to be on the verge of a breakthrough with an injectable anti-cholesterol drug. ... As positive results came out of Amgen’s labs, the price of another drug shocked the health insurance industry: Sovaldi, a hepatitis C cure that its manufacturer, Gilead Sciences, initially priced at $84,000 for a 12-week course. Express Scripts, the biggest pharmacy benefit manager (PBM) in the country, balked at the cost. It eventually refused to include Sovaldi in its 2015 formulary .... That taught Amgen and other drugmakers a lesson. Avoiding hostility with insurers and PBMs is now a paramount industry goal. (Weintraub, 5/28)
Meanwhile, Fred Inc. reports losses due to lower Medicare reimbursements and the U.K.'s Smith & Nephew cuts prices to disrupt the U.S. orthopedics market -
The Wall Street Journal:
Fred’s Swings To Loss Amid Pressure In Pharmacy Business
Fred’s Inc. swung to a loss in its first quarter as the discount retailer’s pharmacy business struggled with lower Medicare reimbursements and higher generic drug costs. The Memphis, Tenn.-based company said slow reimbursements, reimbursement rate reductions associated with preferred Medicare Part D networks, and inflation in generic drugs pressured its pharmacy segment during the quarter. (Beilfuss, 5/28)
The Wall Street Journal:
Smith & Nephew’s Cut-Price Solo Strategy
When prices are falling, apply a little pressure. Tougher pricing for hip and knee replacements helped prompt cost-cutting consolidation in the medical-equipment arena. Zimmer last year agreed to buy Biomet. Stryker also cast an eye over the U.K.’s Smith & Nephew . (Thomas, 5/28)
