WASHINGTON (AP) – Doctors and patients will be able to get more up-to-date information about the risks of the latest drugs as federal health regulators begin posting summarized safety reviews online.
Under a new policy, the Food and Drug Administration said it would begin publishing summaries of potential safety issues with recently approved drugs.
The FDA is tasked with reviewing the safety and effectiveness of all prescription drugs before they reach the market. But some side effects only show up after the drugs are launched and taken by millions of patients across the country. Additionally, most drugs are prescribed for alternate uses and patients groups, giving rise to unforeseen safety issues.
“So that changes the whole game because you don’t know if the drug is effective in that population,” said Dr. Robert Boucher, director of FDA’s office of drug surveillance, at a press briefing.
Typically the FDA only alerts the public when there is a pressing safety issue. But the new updates will provide a comprehensive look at the safety of all new medications approved by the FDA.
The FDA’s safety summaries will incorporate side effect reports from doctors, patients and hospitals as well as the FDA’s own original research. The FDA has collected this information for decades but has only shared it with the public in the occasional press release.
The agency plans to publish the summaries on a quarterly basis. Each new drug, including drugs approved back to September 2007, will receive a safety summary within roughly two years of approval, according to the FDA.
“These summaries will provide clear and useful information in a timely manner that can be used by providers and patients to make informed decisions,” said Dr. Robert Ball, a director in FDA’s center for biologics evaluation.
The new policy is legally required by a 2007 law designed to make the agency more transparent and responsive to drug safety issues.
Congress wrote the law in response to the 2004 scandal involving the popular painkiller Vioxx, which was pulled from the market five years after its approval because of links to heart attack and stroke. Critics said lives could have been saved if the agency had alerted the public earlier to the safety questions surrounding the drug.
Date: June 15, 2010
Source: Associated Press
Filed Under: Drug Discovery
