No therapeutic drug is completely safe, and most compounds' healing powers come with side effects. To help illuminate this double-edged sword, Pfizer (NYSE:PFE) announced yesterday that it was launching a new drug-safety-focused website -- a move perhaps intended to benefit Pfizer's business as much as patients' health.
Pfizer's new website shows patients how to report directly to the FDA if they think they have experienced any serious side effects from a drug they've taken. It also has a heavy focus on explaining the benefits and possible risks associated with Pfizer's drugs, as well as education on judging risk in general. Sure, patients could find the same information on potential drug perils through other sources, but the website does allow Pfizer to show that it's taking drug-safety issues seriously. That said, the company's motives may not be entirely altruistic.
Pfizer's new public emphasis on drug safety follows months of increased FDA focus on drugs' adverse events. As part of the new PDUFA regulations passed last year, the FDA gained increased power from Congress to regulate drugmakers, including ordering them to test their compounds for potential safety issues even after gaining marketing approval.
Many drug developers with recently approved compounds, like Adolor (NASDAQ:ADLR) and GlaxoSmithKline (NYSE:GSK), have also felt the sting of the FDA's new safety-first focus. Approval of the duo's gastrointestinal-disorder treatment Entereg was held up for several months this year, after the FDA ordered both companies to submit a revised risk-management plan to help prevent off-label use of the drug in conditions for which it wasn't approved.
The FDA's renewed focus on drug safety may date back to Merck's (NYSE:MRK) recall of its pain drug Vioxx in 2004. In the past year, Merck and partner Schering-Plough (NYSE:SGP), as well as GlaxoSmithKline, have also all been in the headlines for various perceived miscues about their reporting of adverse events with some of their compounds.
While Pfizer's drug safety website is surely motivated in part by its own long-term benefit -- helping patients understand medicine and risks will probably boost its sales, for instance -- it nonetheless pays to stay on the FDA's good side, too.
