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Biomedical bill aims to fix Cures Act's funding shortfalls for FDA, NIH

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Biomedical bill aims to fix Cures Act's funding shortfalls for FDA, NIH

The heads of the National Institutes of Health and the Food and Drug Administration Dec. 7 praised a bill signed into law last year by former President Barack Obama for providing new tools, resources and authorities intended to help get therapies to the market quicker.

But one year into the 21st Century Cures Act, the initiatives the law created and their related programs lack the funds needed to fully support them, the agency chiefs acknowledged during a Senate Health, Education, Labor and Pensions Committee hearing.

Congress committed to provide $6.3 billion over a decade under the Cures Act, with the majority of those funds — $4.8 billion — expected to go to the NIH for three areas of research championed by Obama: the brain, precision medicine and cancer. The bill also called for $1 billion to be spent over two years on addressing the U.S. opioid epidemic and other mental health issues.

The law also authorized $500 million for the FDA.

But the funding authorized in the Cures Act is discretionary not mandatory, meaning the House and the Senate appropriations committees must allot the money in the annual budget process.

"Cures did not send one single new dollar to these agencies," said Sen. Elizabeth Warren, D-Mass.

The Massachusetts senator said she aimed to fix that problem by introducing legislation that would create a biomedical innovation fund in which Congress would appropriate $5 billion in mandatory funds each year through 2026 intended for various NIH and FDA initiatives.

Warren had tried to get the National Biomedical Research Act enacted as part of the Cures legislation last year, but her colleagues in the Senate snubbed the bill.

But with Cures falling short, "it's time for us to step up and put more money" into the NIH and FDA, she said.

Warren said the new funding could double the number of grants the NIH awards each year.

NIH Director Francis Collins said his agency is currently only able to fund about 19% of the grant applications it receives.

FDA cancer center lacks funds

Even though the Cures Act authorized $1.8 billion over seven years for Obama's and former Vice President Joe Biden's Cancer Moonshot initiative, a program it established, the FDA's Oncology Center of Excellence, or OCE, continues to lack needed funding.

The idea behind the OCE, which officially got off the ground in January, was to bring together the FDA's expert cancer scientists from its three medical product centers — the Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Research and the Center for Devices and Radiological Health — under one umbrella to engage in coordinated evaluations of drugs, biologics, devices and diagnostics.

"This is an extremely important effort on the part of the agency," Gottlieb said. "What we've essentially tried to do is consolidate the clinical portion of the review of oncology products into one combined center."

Gottlieb said the OCE was instrumental in expediting the review of the first two gene therapies approved for the U.S. market — Novartis AG's Kymriah and Gilead Sciences Inc.'s Yescarta.

But the FDA has had challenges in getting the OCE completely operational, he told the Senate committee.

"In all candor, it's related to fully funding it," Gottlieb said.

The FDA is seeking to establish consolidated programs for other therapeutic areas — an approach Gottlieb said is the future of the agency.

"But before we can progress onto other therapeutic areas, we really need to make it work in the oncology setting," he said.

Opioid effort neglected

Research for treatments to address the opioid crisis is another area lacking funding, despite the promised help from the Cures Act, said Sen. Bill Cassidy, R-La.

The budget for the NIH's National Institute on Drug Abuse, or NIDA, only went up by 2% last year, Cassidy said, adding that the amount was out of sync with the disease burden of opioid addiction in the U.S.

NIDA's budget "remains far smaller than other institutes in which there is far less morbidity and mortality flowing from those disease conditions," he said. "So, if we are going to address the issues of opioids or mental health, both of which are playing into this, it seems like there has to be a greater shift in where our funding is going at NIH towards these disease conditions."

Congress could fix the problem by upping the line-item spending for NIDA, Collins said, though he noted that the NIH's National Institute of Neurological Disorders and Stroke and National Center for Complementary and Integrative Health also play roles in opioid addiction research and their budgets also include spending in that area.

"So, one shouldn't look at our organizational structure and say that the money actually fits precisely into those buckets," Collins said.

Two days earlier during a Senate Appropriations subcommittee hearing, Collins had emphasized that the NIH was still waiting for new funding to support a public-private partnership proposed in May to accelerate the development of nonaddictive alternatives to opioids and better overdose-reversal agents.

While as many as 33 drugmakers and other medical product companies have attended meetings with the NIH, none have signed a formal agreement to participate in the partnership.

Stephen Ubl, the head of the Pharmaceutical Research and Manufacturers of America, told the White House opioid commission in late September that companies were waiting for the government to make a firm commitment of providing funds before industry was "prepared to do its share."