Product News and Recalls

Big Pharma joining up to get drugs on market faster

According to an article in the New York Times, 10 of the world’s largest pharmaceutical companies are banding together to form a “nonprofit organization” called TransCelerate BioPharma that will be devoted to streamlining clinical trials and getting drugs on the market sooner.

The report quotes unidentified “people behind the effort” as saying this will be the largest cooperative venture of its kind among the pharmaceutical giants. Garry Neil, the interim chief executive of TransCelerate BioPharma and a former high-ranking executive at Johnson & Johnson, is quoted as saying the budget would be in the millions of dollars.

The 10 initial members of the organization are Abbott, AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, Eli Lilly, GlaxoSmithKline, Johnson & Johnson, Pfizer, Roche’s Genentech division, and Sanofi. The companies’ heads of research and development sit on the organization’s board.

Some of those companies have run into legal trouble over products brought to the market prematurely.

Johnson & Johnson, for example, had two medical devices approved through an FDA loophole that allows products to go onto the market without clinical testing in humans based on their alleged similarity to previously approved devices.

An all-metal hip implant, manufactured by Johnson & Johnson subsidiary DePuy Orthopaedics, was recalled in 2010 after a number of studies showed that nearly half of the devices failed after only a few years, requiring recipients to get additional surgery. The device also generated many complaints about toxic metal debris breaking off and getting into patients’ bodies.

And Johnson & Johnson recalled four different types of the transvaginal mesh implants – used to treat pelvic organ prolapse and urinary incontinence — after hundreds of women who had the devices implanted reported the devices failing, causing chronic pain and injury.

Those two devices alone have generated thousands of lawsuits.

The New York Times reports that the pharmaceutical industry has been struggling to come up with new drugs, despite a vast increase in spending on research and development over the last decade. In the meantime, sales from many big-selling drugs are dwindling as patents expire and generic competition kicks in.

The new “nonprofit” will be based in Philadelphia, the article says.

You should consult with a doctor if you have any ongoing symptoms or health concerns. If you have significant injuries concerning DePuy hips or transvaginal mesh, you should also consult with a lawyer familiar with these cases discuss your legal rights.

See the story here:

http://www.nytimes.com/2012/09/20/health/drug-makers-in-joint-effort-to-streamline-research.html?_r=0