WASHINGTON – Lawmakers found themselves in the unfamiliarterritory of bipartisanship last night, when the House ofRepresentatives voted overwhelmingly in favor of the Food and Drug Administration (FDA) Reform Act. Approved by a 387-5 House vote, the bill sets forth several policyreforms pertaining to drugs and medical devices. The legislationwill increase the so-called user fees drug and medical devicecompanies pay to the FDA and should expedite the review process forthese devices and improve transparency of their clearance process.Lawmakers are expected to have a final draft of the legislation byearly July. [See also: FDA clears mobile radiology app for iPhone, iPad .] The bill – which some observers call a watered-down versionof last week"s Senate-approved legislation – isprojected to reduce the federal deficit by an estimated $370million over the next decade according to the Congressional BudgetOffice. |
Eyeing such savings, lawmakers from both sides of the aislehave overlooked – if only for a brief moment –ideological differences that have often stymied the legislativeprogress in recent years. "Our bipartisan reform package is the culmination of morethan a year of work and negotiations between House Democrats andRepublicans," Rep. Fred Upton (R-MI) wrote this month in theHolland (Mich.) Sentinel. "The FDA Reform Act contains important metrics that will holdthe FDA accountable for its performance, will help provide newtherapies to our nation"s children, significantly improvescientific exchange at FDA"s advisory committees and ensuretransparency and public input in the development of FDA"sguidance documents," Upton added in an Energy and CommerceCommittee press release earlier this month.
[See also: House approves HHS, healthcare IT project funds .] Several of the bill"s highlights: Reauthorizes part of the Pediatric Medical Device Safety andImprovement Act of 2007, which will provide grants to non-profitgroups promoting pediatric medical device development. Approves a five-year price tag of an estimated $6.4 billion in userfees, with $609 million of the pot coming from medical device userfees companies will pay to the FDA; the fees will be used toimprove and extradite the medical device review process, so theycan be available to patients sooner. Expedites the approval process of certain prescription drugs byeasing on some restrictions. Reauthorizes the Best Pharmaceuticals for Children Act (BPCA) andPediatric Research Equity Act (PREA), both which aim to improvesafety and efficacy of prescription drug treatments for children. Addresses national prescription drug shortages by adjustingrequirements when seen fit and would involve providing the publicwith a list of prescription drugs in short supply.
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