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Rep. Tierney seeks more oversight by FDA

PEABODY – Before new medicines are approved, scientists at the U.S. Food and Drug Administration weigh the benefits and any potential downsides, but once in widespread public use, the government agency doesn’t have much oversight over the drug’s impact.U.S. Rep. John F. Tierney wants to change that situation.The Salem Democrat on Wednesday introduced a bipartisan bill that would ensure the FDA has the capability to monitor and protect patient safety after the drug has been approved and released.According to Tierney, the legislation would restructure the FDA by creating a new, independent entity within the agency to review drugs and biological products after they are on the market. U.S. Rep. Jim Ramstad, a Minnesota Republican, joined Tierney in introducing the bill in the House.”OxyContin abuse among teenagers continues to have a devastating effect on families in my district,” said Tierney. “It’s my hope that the additional authorities provided to the FDA in this bill will help prevent the abuse of prescription drugs that are approved in the future.”Tierney said the bill has support from both parties in the House and Senate, and provides the FDA with the necessary tools to make sure certain drugs now on the market are truly safe and effective.Under the present system, the FDA performs a benefit-to-risk analysis to determine whether the benefits of the drug outweigh its potential risks. The FDA then makes a case-by-case determination when evaluating a drug. However, once a drug is approved, the FDA has limited statutory authority to compel corrective action short of actually pulling a drug from the market, according to Tierney spokesman Catherine Ribeiro.With the help of the FDA Safety Act, the new Center for Post-market Evaluation and Research for Drugs and Biologics will be granted significant new authorities. These powers would include requiring post-market study of a drug’s safety or effectiveness and, if subsequently determined a necessity, requiring that corrective action ? such as labeling modifications, distribution restrictions, and establishment of risk management plans ? be taken, Ribeiro said.”The FDA must have a meaningful way to oversee drug safety once a drug is on the market so we can protect patients,” Ramstad added.Sen. Chris Dodd, a Connecticut Democrat, and Sen. Chuck Grassley, an Iowa Republican, introduced an identical version of the bill in the Senate.”The FDA Safety Act will bring a new level of priority and independence to the post-market surveillance of drugs,” said Dodd. “A crisis of confidence in the FDA currently exists. If we are to restore public confidence in the words ?FDA Approved,’ we must ensure that the men and women who diligently monitor drugs on the market have the resources, the independence, and the authority to do their job effectively.”The FDA’s credibility was called into question during the so-called Tobacco Deal trials of the 1990s, when it was shown the agency for 40 years did little to control the addictive drug Nicotine, found in cigarettes. The FDA maintained, as did the tobacco companies, that Nicotine was simply an additive rather than a drug. As a result, the FDA claimed it had no jurisdiction in the matter. Further studies proved Nicotine is addictive.

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