Plans by the US Food and Drug Administration to launch a drug watch facility for consumers on its website could result in “irrational fears,” according to the pharmaceutical industry body, PhRMA.
In comments to the agency, reported by Reuters, PhRMA said the information: "Is too vague and preliminary to be of any value in making informed treatment and prescribing decisions. Such information is...not likely to accomplish anything other than confusion among physicians and the public and creation of irrational fears about the safety of drugs on the list.”
The drug watch site was forged in the wake of accusations the agency had failed to act early enough to withdraw Merck & Co’s Vioxx from the market on concerns of a link to heart attack and stroke. In November 2000, a clinical trial - Vigor - found a five-fold increase in heart attack risk with high-dose Vioxx; yet the company said the drug was safe and that the comparison drug, naproxen, was exerting a cardio-protective effect. A 2002 trial reported a two-fold increase in heart attack risk with high-dose Vioxx and another study reported that naproxen did not affect heart attack risk. Then, in March 2004, another study reported that both high-dose and low-dose Vioxx increased the risk of heart attacks compared to Vioxx's leading competitor, Pfizer's Celebrex (celecoxib) [[191104a]]. It was not until the end of September 2004 that Vioxx was removed from sale globally [[01/10/04a]]. Then, In November, study data were put on the FDA website, estimating that nearly 28,000 excess cases of heart attack or sudden cardiac death were caused by Vioxx [[03/11/04a]].
On its site, the FDA notes that it “is launching a new program to make drug safety information available to you in an easily accessible format. Because patients are taking a more active role in their healthcare, we want to make safety information available about the medicines they are using. We believe that patients, their healthcare professionals, and other consumers will find the information we are providing useful in their prescribing and treatment decisions.”
Meanwhile, the FDA is reportedly looking to strengthen its inspection rules for pharmaceutical manufacturing, according to a press release issued by BioMed News. FDA Commissioner, Lester Crawford said at IBC's Drug Discovery Technology & Development Conference: “In order to maintain the American public’s confidence in FDA’s protection of public health, it is essential that the agency implement and enforce good manufacturing practices. The FDA’s overhaul of the pharmaceutical cGMPs encourages manufacturers to modernise their methods, equipment and facilities that will help eliminate both production inefficiencies and undue risks for consumers. Our initiative also implements tougher inspections rules to make them more targeted and effective.”