Republican members of Congress are reportedly pressing Democrats and the White House to accept a deal to fund the government that would include a number of significant regulatory reform measures, reports the publication National Review.
In documents obtained by the media organization, Republicans lay out a series of demands-spending reforms, entitlement reforms for government employees, health spending reforms, and a one-year delay of the Patient Protection and Affordable Care Act ("Obamacare") among them.
But they are also calling for a number of other regulatory reform provisions that have long been flagged by progressive regulatory groups-and some in the life sciences industry-as being problematic.
The most prominent of the reform measures would be the adoption of the Regulations from the Executive in Need for Scrutiny (REINS) Act. The legislation was introduced by Sen. Rand Paul (R-KY) in January 2011, and has since been reintroduced in 2013.
"This legislation would require Congress to approve every new major rule proposed by the Executive Branch, which has an annual economic impact of $100 million or more, before it can be enforced on the American people," Paul explained in a statement in 2011. The bill "would allow for Congress to regain their constitutional authority by limiting the size and scope of rule-making powers, without oversight, by the Executive Branch," he added.
The Republican-controlled House of Representatives has passed the bill several times, but it has yet to make it through the Senate, which has been controlled by Democrats since Barack Obama was sworn in as president in January 2009.
National Review, which posted a summary-but not the original text-of the concessions Republican members of Congress are hoping to extract from their political counterparts, also included unspecified "regulatory process reform[s]" and changes to the process by which regulatory agencies enter into consent decrees with companies-a tactic often used by the US Food and Drug Administration (FDA) when it wants to ensure long-term compliance by companies with a history of major or ongoing deficiencies.
If no agreement is reached by 31 September 2013, the government's current budgetary authority will run out, forcing most agencies-including FDA-to furlough all "non-essential" staff. FDA has thus far refused to comment on the details of its shutdown plan, saying only that the agency is aware of the impending deadline.
The new bargaining situation further raises the stakes for the agency. While FDA releases few rules with an economic impact as high as $100 million, some, such as the Foreign Supplier Verification Program (FSVP), far exceed the expected costs. The other, unspecified regulatory changes might also impact the agency, depending on what those changes come to include.