Senate Approves 21st Century Cures Act, Sending Bill to Obama

Xconomy National — 

The U.S. Senate has voted overwhelmingly to approve the 21st Century Cures Act, a wide-ranging healthcare spending and reform bill that aims to infuse medical research with new funding and also speed up the regulatory approval process for new drugs and medical devices.

With the Senate’s 94-5 vote on Wednesday, the bill now advances to President Obama, who is expected to sign the bill into law. The U.S. House of Representatives last week voted 392 to 26 to approve the Act.

Provisions of the Cures Act include $4.8 billion to support the National Institutes of Health to support research in cancer, neuroscience, and precision medicine; $1 billion to distribute as state grants for opioid addiction programs; and $500 million allocated to the FDA for unspecified “innovation” programs.”

Some consumer groups have criticized the Cures Act as a weakening of the FDA approval process. But the Cures Act has received bipartisisan support, though questions remain regarding funding for the measure. The bill calls for the money to come from a public health fund that was created by the Affordable Care Act. That law’s future is in question, given President-elect Donald Trump’s pledge to repeal and replace the law. While several replacement plans have emerged, there is no consensus on any single plan, which makes the future of any funding provided under the ACA unclear.

The Trump administration also could have broader impact on the pharmaceutical industry. Trump, named Wednesday by Time magazine as 2016’s “Person of the Year,” told the magazine that he “doesn’t like what’s happened with drug prices.” Though Trump offered Time no drug pricing policies or plans, he vowed to bring down the cost of prescription drugs. The Nasdaq biotechnology index, which tracks the stock prices of biotech and pharma companies, dipped nearly 3 percent on Wednesday.

The Cures Act and the change in political power come at a time of transition at the FDA. John Jenkins, the agency’s director of the Office of New Drugs, announced on Monday that after 25 years at the FDA he would retire effective January 6, according to Regulatory Focus. Jenkins was among the FDA staffers who opposed the approval of the Sarepta Therapeutics (NASDAQ: SRPT) drug eteplirsen (Exondys 51).

In becoming the first treatment for the rare disease Duchenne muscular dystrophy, the Cambridge, MA-based drug developer overcame objections of the FDA’s drug review staff and complaints to FDA Commissioner Robert Califf. Califf deferred to Janet Woodcock, the agency’s top drug evaluator, who approved the drug. Jenkins publicly criticized the decision in comments made at a meeting of the National Organization of Rare Disorders, describing the precedent set by Sarepta as “not a good model for other development programs.”

While the FDA searches for Jenkins successor, Woodcock will take over Jenkins’ role, Regulatory Affairs reported.