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US funding on research could surge

Critics say legislation threatens drug safety

The legistlation was co-sponsored by US Representative Joe Kennedy III.Elise Amendola/AP

WASHINGTON — It was a rare show of bipartisanship: Republicans and Democrats on a House committee voting 51-to-0 recently to shower billions of dollars in scientific grants on research institutions from Massachusetts to California, the largest increase in a decade.

The legislation, co-sponsored by US Representative Joe Kennedy III, promises a bonanza for Massachusetts, perennially the top receiver of National Institutes of Health grants per capita and home to a booming biotech and medical-device industry that grew out of the Boston area’s concentration of academic medical centers.

But the $8.75 billion in new NIH grants over the next five years — expected to come to the House floor for a vote this week — comes at a cost that’s too high in the eyes of critics. They say the bill, backed by the pharmaceutical, biotechnology and medical-device industries, would weaken Food and Drug Administration scrutiny and jeopardize patient safety.


“This bill has turned into a Christmas tree for the drug and device industry,” said Dr. Jerry Avorn, a Harvard Medical School professor and a physician at Brigham and Women’s Hospital. “It seems to be driven by a misperception being pushed heavily by lobbyists that drug development is being impeded because the FDA is too slow and has unreasonably high standards, neither of which are true.”

The debate crystalizes the competing interests for industry and government — fighting disease while making sure patients and taxpayers are protected from drugs and devices that don’t work, or even worse, cause harm.

Despite critics’ concerns, the sweeping legislation, known as “21st Century Cures,’’ is likely to pass the full House with overwhelming support on Friday. It would be an accomplishment for Republicans leading the effort, showing that they could govern in an era marked by partisan rancor. The Senate is working on its own version.


Congressional leaders hope to finalize a package by the end of the year, with new money starting to flow to the NIH in October 2016. The Obama administration is generally supportive of new NIH money, and the president included a $1 billion boost in his proposed budget for the next fiscal year.

After a large infusion of funding in the 1990s for the NIH, the country’s main sponsor of medical research, spending has been flat since 2003, creating growing political pressure from industries and regional congressional delegations for increases. Six of Massachusetts’ nine House members have already signed onto the bill.

“There are potential treatments out there that are getting held up in the approval process and patients are dying,” said Kennedy. He said the bill would “streamline the bureaucratic process without making important compromises on safety.”

A fellow Massachsuetts Democrat, Senator Elizabeth Warren, who is working on her own bill to boost NIH funding, disagrees.

“Many Republicans in Congress are focused on lowering the FDA standards for approving drugs. That’s a dangerous game,” said Warren, a member of the Senate Health, Education, Labor and Pensions Committee.

Republicans have long sought to rein in the Food and Drug Administration and provide faster, easier approvals for new medical treatments. They contend an overhaul of safety reviews is needed to help patients as well as the economy. The FDA’s average standard new drug approval was 10 months, according to an analysis this year by PricewaterhouseCoopers, which reviewed 2012 data.

The bill would allow the FDA to approve new medical devices based on limited patient case studies and medical journal articles instead of extensive clinical trials, and allow companies to make changes to their devices without FDA approval. It also would allow approvals based on “biomarkers,” such as a drug’s effect on a tumor, rather than improvements in patient survival.


To encourage companies to develop new antibiotics, which are not as lucrative as other drugs, the bill would provide a financial bonus to hospitals for administering antibiotics approved under the FDA’s new, shortened timeline.

Currently, manufacturers are granted exclusive rights to sell certain drugs that can last as long as five to 12 years, before generic competition is introduced. The bill would extend that market exclusivity by six months if drug companies can show their drug also works in treating a rare disease. The extension would stave off generic competition and cost the federal government $848 million over 10 years, according to a Congressional Budget Office analysis.

“It’s a fantastic free lunch,” Avorn said of that provision, likening the bill to a “publicly supported monopoly tax.”

Jeff Ventura, a senior FDA advisor, said the agency supports the bill’s overall objectives and is paying close attention to the balance between patient access to new drugs and preserving FDA safety standards.

Massachusetts drug and device industry groups challenge the notion that the bill would put patient safety at risk.

“This is not a giveaway go the device and pharmaceutical industries by any means,” said Tom Sommer, president of the Massachusetts Medical Device Industry Council. “We’re not asking for anything other than to approve safe and effective devices in a more expedited fashion.”


Sarah MacDonald, executive vice president of the Massachusetts Biotechnology Council, said, “Making the approval process faster isn’t necessarily a bad thing. Fast can still be deliberative and conservative.”

Work on the bill began in the House a year and a half ago, with the Energy and Commerce staff gathering ideas from FDA officials, patients, and industry executives, said a committee staffer.

To pay for the new NIH spending, the committee has proposed selling off crude oil from the nation’s Strategic Petroleum Reserve.

Heritage Action, a conservative group, is putting pressure on Republicans to vote against the bill. The group came out strongly against the bill this week because it sidesteps budget caps in place since 2011. The Strategic Petroleum Reserve, Heritage Action said, “is not a piggy bank for lawmakers to use to offset their desire for immediate spending increases.”

Many Democrats face constituent pressures — from needy patients suffering from disease as well as drug and device industries in their districts — to back the bill and feel this is the surest path toward increasing research dollars whose purchasing power has eroded over the last 12 years.

“Because of the pressures and interests in boosting NIH funding in a way that’s feasible in this political climate, people are basically willing to throw the FDA under the bus,” said Vijay Das, a health policy expert at Public Citizen, a watchdog group with a focus on patient safety.


Tracy Jan can be reached at tracy.jan@globe.com. Follow her on Twitter @TracyJan.