New Federal Drug Safety Bill Signed Into Law

Some details not noted below - Among the many reforms, this new law gives the FDA the authority and money to monitor, investigate, report (and take action) on adverse side effects of drugs once they are on the market. It also requires all PRINT ads (Magazines, newspapers etc) to say: "You are encouraged to report side effects of prescription medication to the FDA's medwatch call 800# or log onto www.fda....." In six months the Secretary of Health and Human Services must make a report to Congress on how they can implement this in TV ads.

As seen in this report

The Food and Drug Administration on Thursday gained broad new powers to ensure the safety of prescription drugs used by millions of Americans under a bill President Bush signed into law.

At its core, the new law renews for five years programs to collect fees from drug and medical device manufacturers. The industry money accounts for about one-quarter of the FDA's overall budget, defraying the cost of reviewing products that need agency approval.

Members of Congress, acting in the wake of the withdrawal of the painkiller Vioxx three years ago, seized on the bipartisan legislation as a vehicle to reform the FDA's handling of drug safety.

In part, the legislation shifts more of the FDA's attention from experimental drugs pending approval to those already are on the market, and gives the agency more power to act when worrisome problems emerge.

"It really represents an important addition to the FDA's authority," said FDA commissioner Dr. Andrew von Eschenbach.

It gives the FDA the power both to require drug companies to do further study on the safety of medicines, if needed, and to mandate new label warnings when problems do appear. The FDA also gains the ability to fine companies to ensure compliance with those two new authorities. The legislation further requires companies to publicly release results of all clinical trials that show how well their approved drugs performed. Not yet approved drugs could be subject to the requirement later.

Still, how the Food and Drug Administration Amendments Act of 2007 will change the agency remained unclear, beyond the expected hiring of several hundred new employees.

The FDA was still reviewing the 156-page law and its roughly 200 specific provisions, many with timelines, before deciding how to implement them. The fine-print list of actions the FDA must take runs more than 10 pages, said Randall Lutter, the agency's deputy commissioner for policy. The FDA may have to draft new regulations or guidelines - a process that can take years - to implement some of those provisions, Lutter said.

The legislation does spell out that the FDA will be able to fine drug companies for not completing follow-up studies on their drugs after they've won government approval. Those studies frequently remain undone, often leaving important safety questions unanswered.

The bill calls for drug companies to pay $393 million, and medical device makers $48 million, in various fees next year.

"The increased fees will allow the agency to expand drug safety monitoring, hire additional staff for post-market surveillance, and modernize its information technology systems," said Billy Tauzin, head of the Pharmaceutical Research and Manufacturers of America.

It also requires the FDA to step up its active surveillance for new safety issues with drugs. That system traditionally has been largely passive.

"We welcome the ability to really engage in how those products perform once they are out on the market," said Dr. Janet Woodcock, the FDA's deputy commissioner and chief medical officer, citing the use of data-mining techniques to sift through electronic medical databases for hints of problems.

The manufacturers of certain new drugs will have to draft for each one a so-called "Risk Evaluation and Mitigation Strategy" that can include medication guides distributed with each prescription to ensure the medicine's safe use.

Under the legislation, the FDA will set up a registry to log incidents where adulterated food could pose a health risk. The agency also will have to establish pet food ingredient and processing standards - a provision born of the massive dog and cat food recalls earlier this year.

"It strengthens safety rules for the wave of new miracle drugs coming on the market that Americans count on to protect their health. It brings needed reassurance to families that the food they feed their pets is safe," said Sen. Edward Kennedy, D-Mass.