Healthy Skepticism Library item: 11027

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

Goldstein J.
Could Stricter Safety Rules Help Drug Makers?
The Wall Street Journal Health Blog 2007 Jul 18
http://blogs.wsj.com/health/2007/07/18/could-stricter-drug-safety-rules-help-drug-makers/?mod=yahoo_hs

Full text:

Conventional wisdom holds that the stricter drug-safety rules in the offing in Washington could burden the drug industry and harm sales. But in a post this morning, the In Vivo Blog argues that the tougher safety rules could help industry by boosting the odds that drugs go to the right patients and by making it easier for drug makers to weather safety problems that arise after drugs make it to market.

The In Vivo case study is Xolair, an asthma drug co-marketed by Novartis and Genentech. The drug, given by injection, carries a black-box warning about a life-threatening but rare allergic reaction called anaphylaxis. Genentech is using a multi-pronged pronged strategy to manage the drug’s safety issues, In Vivo write, and the approach incorporates measures that the FDA could soon begin imposing more often.

The safeguards include giving patients a brochure about the risks before each injection; asking doctors to keep patients in the office after the injection for observation; conducting follow-up surveys with doctors and patients; creating a database that will allow researchers to compare patients who had serious reactions against patients who did not; and trying to come up with a skin test that will predict which patients are likely to have serious reactions.

The risk-management plan “cements the company’s position with providers and assures that the product will be restricted to a very sick group of patients: a group which justifies the current high cost of the treatment,” In Vivo argues. “If FDA’s new authority makes more companies adopt plans like this, the industry could be headed into a period when postmarketing problems become resolvable and not the cause of sudden product withdrawals.”