Revised FDA bill would cut deficit by $370 million
A summary of the revised bill says it became compliant with pay-as-you-go rules in part because new rules for petitioning the FDA were applied to more products. The rules require the FDA to respond more quickly to petitions that can delay the approval process for new drugs.
{mosads}The main purpose of the FDA bill is to reauthorize user fees the agency collects from drug and medical device companies. It also creates a new fee for the companies that make generic drugs and makes several changes to the FDA’s regulatory policies.
The bill is slated to come up this week under special rules that require a two-thirds majority to pass. It enjoys broad bipartisan support in both chambers, and House leaders have said the goal is to get a finished bill to President Obama’s desk by July 4.
The Senate approved its version of the FDA bill last week by a 96-1 vote. Sen. Bernie Sanders (I-Vt.), a fierce critic of the pharmaceutical industry, was the lone “no” vote.
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