New Bill Strengthens US Regulator's Drug Safety Powers

Under the new ruling, drug firms will monitor drugs before and after FDA approval The US Congress has approved a radical overhaul of the US Food and Drug Administration's regulatory powers in an attempt to offer patients better protection from drugs once they enter the market. The legislation received full Senate approval on September 20th, and is now anticipated to be made legal by George W. Bush, the US President. In essence, the ruling provides the US FDA with heightened authority to examine drugs' performances when they are in the public domain. Additionally, it makes it mandatory for drug manufacturers to make safety information public.

According to Democrat Senator Edward M Kennedy - the Chairman of the Health, Education, Labor and Pensions Committee - the new rule "..ought to be reassuring for every family about the safety of their prescription drugs."

Under the terms of the new regulation, the US FDA can demand that drug firms keep a close eye on medicines that have recently been approved. Within these examinations, the firms would look out for evidence of risk, in much the same way as they would during the initial trial period leading to regulatory approval.

The rules allow the US FDA access to Medicare's vast expanse of patient databases, as well as health insurance firms' archives, in order to research drug performances.

Additionally, it will be able to demand rapid changes in drugs' labels if a risk factor needs to be added. Furthermore, it will have the rights to preview the latest drug TV campaigns before they hit the screen.

According to Dr Steven Nissen: "(the ruling) means this history of never showing studies that show safety problems will end". He added: "It's not a perfect bill -- no legislation is -- but in the key areas, the bill moves us forward toward safer and more effective drugs". Dr Nissen is the heart specialist who, earlier in 2007, highlighted the association between GlaxoSmithKline's Avandia diabetes drug, and an increased risk of cardiovascular problems developing among its users. The situation stands as one of the prime reasons the US FDA has taken so much criticism in recent months.

Before then, however, was the very high-profile Vioxx case in 2004, the areas exposed in which, the new bill attempts to remedy. Historically, the US FDA's powers were primarily restricted to reviewing a drug's safety and efficacy prior to its market debut. It had much less authority to limit the use of drugs linked to safety concerns after its own approval has been given.

Consequently, the regulator has been reliant on drug manufacturers and doctors to inform of any side effects, but, in many instances, the companies failed to implement a post-approval strategy.

Patients carried on using the likes of Avandia and Vioxx, said the critics, while the US FDA's confirmation of their side effects was delayed.

Donald Kennedy worked at the US FDA in the late 1970s. Describing the FDA's most significant problem, in respect of drug safety, as the slowness of the information gathering procedure, Mr Kennedy applauded the new bill. He urged, now, for Congress to fund the US FDA as appropriate.

In the words of the former commissioner of the US FDA - Dr Scott McClellan - "From the standpoint of drug safety, this is the most extensive piece of legislation we've seen in 40 years."