Congress set to vote on bill that promises to speed up drug approval – Washington Post

 In Health

(Jason Reed/Reuters)

A 996-page bill that seeks to speed up the approval of new medicines and medical devices is expected to head to the House for a vote Wednesday, amid criticism that the complicated legislation is being rushed through without sufficient scrutiny.

Called 21st Century Cures, the legislation earmarks $6.3 billion for biomedical research, opioid abuse prevention and support for the agency that oversees the safety of drugs. It also contains multiple provisions that aim to ease the requirements for drugmakers seeking approval from the Food and Drug Administration to sell their products.

The bill has had broad bipartisan support, but consumer advocates have criticized the bill, saying that there are major trade-offs that could weaken the FDA’s regulatory power and potentially put patients in harm’s way. And some legislators, including Sen. Elizabeth Warren (D-Mass.), say the regulatory changes in the bill amount to a giveaway to the pharmaceutical industry.

The legislation has been supported by drug and medical-device companies and patient groups, and has been the subject of intense lobbying. According to the Center for Responsive Politics, more than 1,400 lobbyists have pressed for the bill on behalf of clients, including drug companies and universities, that could benefit from an increase in federal biomedical research funding.

A spokesman for the FDA said the agency does not comment on pending legislation.

A previous version of the bill sailed through the House more than a year ago but has been stalled in the Senate. The new version, unveiled by House and Senate leaders over the holiday weekend, contains changes intended to smooth its passage through both houses.

Rep. Fred Upton (R-Mich.) and Sen. Lamar Alexander (R-Tenn.) together introduced the final version of the bill over the Thanksgiving weekend, and in a joint statement they called it “an innovation game-changer, a transformational bill to bring our health infrastructure light years ahead.”

Funding medical research

There are popular provisions sprinkled through the legislation, including an additional $4.8 billion in funding for the National Institutes of Health over 10 years, $500 million for the FDA over a decade and $1 billion for opioid abuse prevention over two years. Its proponents are touting the support it will bring for initiatives such as Vice President Biden’s cancer moonshot and President Obama’s precision medicine initiative.

In a speech Monday afternoon on the Senate floor, Warren called the funding for NIH and opioid abuse prevention a “tiny fig leaf of funding” that masks provisions that benefit the industry.

“Why bother with a fig leaf in the Cures bill? Why pretend to give any money to NIH or opioids?” Warren said. “Because this funding is political cover for huge giveaways to giant drug companies. There are more examples than I can count.”

The funding is less than many had hoped; the original bill called for $8.75 billion over 5 years for NIH. The bill authorizes $1.8 billion “to support cancer research” over five years — the Obama administration’s “cancer moonshot” program, though the legislation doesn’t use that phrase. The funding would begin with $372 million for the current fiscal year, far less than the $700 million or so that the administration said it was seeking a few weeks ago. Still, cancer-research advocates were relieved that the legislation contained money for the initiative and said that they hoped to build on it in the future.

Jon Retzlaff, managing director of science policy and government affairs at the American Association for Cancer Research, called the $372 million “a down payment for a historic effort,” adding that the anti-cancer campaign will require “robust, sustained and predictable annual funding increases” over the next several years.

Senate Majority Leader Mitch McConnell (R-Ky.) has called the bill the most important legislation before Congress this year.

“Cutting back on bureaucratic red tape, advancing lifesaving research and tackling the scourge of cancer would move our country forward and help millions looking for more than hope, but a chance at long, healthy lives,” McConnell said.

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