Medical Devices and Prescription Drug Policy

Thirty-seven Democrats joined Republicans in voting to repeal the healthcare law tax despite a veto threat from President Obama.

The House voted Thursday to advance legislation that would repeal the 2.3 percent medical device excise tax imposed by the Democratic healthcare law in 2010, which would raise an anticipated $29 billion over the next decade.

Members approved the rule for the legislation, H.R. 436, in a mostly partisan 241-173 vote, although eight Democrats joined Republicans in support of the rule.

A coalition of healthcare advocates said Monday that Congress should force the Obama administration to issue new regulations on medical devices.

The Advancing Patient Safety Coalition urged lawmakers to address the issue as they work out the differences between the House and Senate versions of a must-pass Food and Drug Administration bill.

Every five years, Congress must reauthorize user fees the FDA collects from drug and device companies. Lawmakers traditionally use the bills to make additional changes to FDA policy.

The last reauthorization, passed in 2007, called for a "unique device identification" (UDI) system to better track devices and monitor potential safety risks. But regulations to implement the UDI have been stuck at the Office of Management and Budget for nearly a year.

House Republicans will look to pass legislation next week that they say will help lower healthcare costs, something the GOP says the 2010 healthcare law has failed to do so far.

Republicans plan to bring up the Health Care Cost Reduction Act, H.R. 436, which combines three bills Republicans have proposed over the last year.

A bill reauthorizing and expanding a user-fee program for drugs and medical devices was approved by the House on Wednesday, sending the bill to a likely conference with the Senate.

The House approved H.R. 5651, the Food and Drug Administration Reform Act, in a 387-5 vote. The bipartisan bill is similar to a Senate-passed bill that would extend the FDA's user-fee program for generic drugs and biosimilars.

House Speaker John Boehner (R-Ohio) on Wednesday cast a bipartisan Food and Drug Administration bill as a job-creation measure and tied the bill to the GOP's efforts to repeal President Obama's healthcare law.

The House is scheduled to vote Wednesday on the FDA bill, which reauthorizes user fees that the FDA collects from drug companies and medical-device manufacturers. The drug and device industries support roughly 6 million U.S. jobs, Boehner said in a statement.

"Unfortunately, our nation’s device and biopharmaceutical leadership is under threat," he said. "Because of the lack of predictability, consistency, transparency and efficiency at the Food and Drug Administration, U.S. device and drugs jobs have gone overseas and foreign patients, not U.S. patients, have been the first to benefit from U.S. innovation."

House Republicans have changed their Food and Drug Administration bill enough to get a positive score from the Congressional Budget Office.

The FDA bill is set for a floor vote this week. A new CBO analysis says the amended bill would reduce the deficit by $370 million over the next decade. The version that passed the Energy and Commerce Committee earlier this month would have added nearly $250 million to the deficit, according to CBO.

The Senate overwhelmingly passed a major Food and Drug Administration reauthorization on Thursday after defeating more controversial amendments designed to lower the price of prescription drugs.

The bill, which reauthorizes user fees the Food and Drug Administration collects from drug and device companies, passed 96-1. Sen. Bernie Sanders (I-Vt.) was the only “no” vote. There’s also broad bipartisan support for the House version, which cleared the Energy and Commerce Committee by a voice vote and is awaiting a vote on the floor.

Both bills would reauthorize existing user fees and create a new fee for companies that make generic drugs. The firms have complained about long backlogs of applications at the FDA, leading to delayed approvals.

Senate Majority Leader Harry Reid (D-Nev.) praised Sens. Tom Harkin (D-Iowa) and Mike Enzi (R-Wyo.) for their bipartisan work to get the bill out of committee quickly and easily.

“It's exemplary for what the rest of us should do. I appreciate very much the work they have done. I repeat, it's how we should get other work done,” Reid said.

Read more...

The Senate defeated an amendment that would have let Americans buy drugs from Canadian pharmacies.

Sen. Grassley said Obama "shouldn't have made a deal with the pharmaceutical companies on ObamaCare two years ago."