Fewer blockbuster drugs losing patent protection, the Supreme Court ruling allowing lawsuits against patent settlement deals, a decision allowing generic-drug-makers to update labels based on new safety information and higher FDA user fees combine to create a challenging business climate for the generic-drug industry, a Moody's Investor Service report finds.
Sen. Charles Grassley, R-Iowa, has requested information from Walgreen leadership on the drugstore chain's participation in the 340B drug discount program, including a rundown of profits generated through the program and details on financial arrangements for the top 100 drugs dispensed under the program.
Pharmacy benefit manager Express Scripts has partnered with Walgreen to launch Smart90 Walgreens, designed to promote adherence and savings with 90-day prescription fills. "Over the past few years, our Smart90 program has driven more 90-day prescriptions for participating clients, and we're pleased to now offer this additional option," said Glen Stettin, senior vice president of research and new solutions with Express Scripts.
Rep. Frank Pallone Jr., D-N.J., announced his sponsorship of the Medicare Prescription Drug Integrity Act, which would require verification that any prescription for a drug on the Controlled Substances list was written by an authorized health care provider before it is covered. The bill also would require restricted access for beneficiaries suspected of abusing or diverting drugs and would give HHS new fraud-fighting tools.
The FDA issued a draft guideline for Generic Drug User Fee Amendments to the Prescription Drug User Fee Act. The agency's website features documents including guidance for generics-makers on self-identification of generic-drug sites, organizations and facilities, as well as questions and answers about the guideline. FDA officials and drugmakers are hoping that the amendments will guarantee faster review of generic-drug applications and reduce backlog.