Product News and Recalls

J&J seeks priority review for new drug

The U.S. Food and Drug Administration intends to give priority review to Johnson & Johnson’s experimental treatment for multidrug-resistant tuberculosis.

According to a story in the Newark Star Ledger, Johnson & Johnson’s Janssen Research & Development unit applied for approval to market bedaquiline, or TMC207, on June 29. The drug would be included in combination therapy for adults with multidrug-resistant tuberculosis lung infections.

Under the FDA’s standard review process, the agency aims to approve drugs within 10 months. But priority review shortens that span to six months from the application’s submission because it may offer a major advance or treat a condition with few or no existing therapies.

Johnson & Johnson’s attempts to expedite the FDA’s standard review process have caused problems for the company and consumers in the past.

Both an all-metal hip implant manufactured by Johnson & Johnson subsidiary DePuy Orthopaedics and a transvaginal mesh implant designed to treat urinary incontinence and pelvic organ prolapse were approved under the FDA’s 510(k) process.

Under 510(k), a medical device automatically gets approval if it’s deemed “substantially equivalent” to a previously approved product.

The DePuy Orthopaedics hip implant was recalled in 2010 following complaints that nearly half failed within a few years, making further surgery necessary. Complaints also included metal debris breaking off and getting into patients’ bloodstream.

And Johnson & Johnson recently recalled four different types of the transvaginal mesh implants after hundreds women who had the devices implanted filed lawsuits alleging that they caused severe pain and injury including organ perforation.

Bedaquiline would be the first drug specifically for multidrug-resistant tuberculosis, and the first new type of TB drug in more than four decades.

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.nj.com/business/index.ssf/2012/09/fda_sets_johnson_johnsons_tb_d.html