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February 06, 2007

Healthcare & The FDA

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Now that the Democrats are back in power healthcare reforms may soon affect the drug industry. Discussion surrounds reforming the FDA as to create tougher safety rules as well as reduce the cost of prescription drugs. It is also a possibility that a new wing of the FDA will be created which would create focus specifically on prescription drug regulation. This branch would have the jurisdiction to change labels on medicines, regulate advertising, and fine those that are not complying to prescribed regulations. Since Democrats are in power it is less likely that they would depose legislation that would bestow more authority to regulatory committees as they view this move as one that would please consumers. Some Republicans also support this democratic view because of past drug-safety problems such as the recall of Vioxx. Furthermore, 2007 calls for a contract renewal which stipulates how much the healthcare industry will contribute to fund regulatory FDA processes. Some argue that addressing other regulatory issues other than the contract for the amount of money that the healthcare industry will contribute to regulatory processes could delay the renewal of this contract and be rehabilitating to the current FDA regulatory body. The new legislation proposed would also create a path for a new FDA agency to approve generic biotech drugs. This could benefit generic drug producers as this body could help speed up the approval process and allow generic manufacture to enter the market sooner.

Companies to Keep an Eye On Include:

Posted by jcip at February 6, 2007 09:29 PM