- GSK resumes some doctor payments, backtracking on blanket ban
GlaxoSmithKline, which five years ago stopped paying doctors for promoting its drugs, said...it would allow such payments once again in limited circumstances...The British group’s 2013 no-payment pledge marked a first for an industry battling past scandals over sales practices. But other drugmakers failed to follow suit, leaving it at a competitive disadvantage...Drugmakers have long used so-called key opinion leaders to promote the benefits of their products to other prescribing physicians and the decision to abandon this strategy was questioned by a number of analysts...GSK’s new updated policy...will now permit payments to global experts who speak about the science behind novel new medicines...“These changes are being made for a select number of innovative products in a limited number of countries and apply to restricted time periods in a product’s lifecycle,” the drugmaker said.
- New law restores lost time for makers of some drugs (statnews.com)
President Obama has signed a law that resets approval dates for some medicines that contain controlled substances. The goal is to streamline the process used by the Drug Enforcement Agency to place prescription drugs that are controlled substances on a list of medicines for which distribution is restricted…the new law ensures that a company offering such medications will not effectively lose time from a five-year period under which it can exclusively market the drugs…Drug makers have griped they are often at a competitive disadvantage, since controlled substances must first be placed on the DEA list before they can reach pharmacies. Companies have complained the process is often lengthy and hampers their ability to take advantage of a five-year marketing exclusivity period following Food and Drug Administration approval during which generic competition is delayed…the Improving Regulatory Transparency for New Medical Therapies Act, would require the DEA to list a drug within 90 days after receiving notice from the FDA...
- Federal judge refuses to halt diabetes drug transparency law (reviewjournal.com)
A federal judge...denied a request by pharmaceutical companies to immediately block a Nevada law requiring them to detail diabetes drug prices and disclose manufacturing costs and research investments come July...The reason, he said: July is more than nine months away...“I don’t see immediate and irreparable harm here,” U.S. District Judge James Mahan said after hearing arguments for and against the request in Las Vegas. Mahan said he might reconsider if the request were made in March or April, but he facetiously added, “My crystal ball is broken.”...At Tuesday’s hearing, Robert Weiner, who represented the pharmaceutical groups, argued that acts as a penalty for companies wanting to raise prices after Nov. 1 and before the July disclosure date...“This is a competitive disadvantage, and it chills us now,” Weiner said...Arguing against the injunction, Las Vegas Chief Deputy Attorney General Linda Anderson said the law is intended to protect diabetes patients in Nevada.
- NFL abuse of painkillers and other drugs described in court filings (washingtonpost.com)
National Football League teams violated federal laws governing prescription drugs, disregarded guidance from the Drug Enforcement Administration on how to store, track, transport and distribute controlled substances, and plied their players with powerful painkillers and anti-inflammatories each season, according to sealed court documents contained in a federal lawsuit filed by former players...testimony and documents by team and league medical personnel, describes multiple instances in which team and league officials were made aware of abuses, record-keeping problems and even violations of federal law and were either slow in responding or failed to comply...
- Disregarding federal laws
- Reliance on pharmaceuticals
- Lining up for the ‘T Train’