Far-reaching 21st Century Cures Could Send Ripples Through Indiana

Dec 2, 2016

Credit Global Panorama / https://www.flickr.com/photos/121483302@N02/

A $6 billion healthcare bill making its way through Congress could have significant effects on health, industry and research in the Hoosier State.

The 21st Century Cures Act was approved by a wide majority in the House Wednesday. It offers up nearly $5 billion in research spending through the National Institutes of Health, which funnels the cash to schools such as Purdue and Indiana University.

In addition to the research funding, the Cures Act would speed up FDA approval for new medical devices and pharmaceuticals, a boon to the state’s biosciences industry, which, according to the Indiana Business Research Center, is responsible for one-third of Indiana’s total exports.

Rep. Susan Brooks (R-5th) says reps from Indiana medical sciences companies have been watching the legislation closely. Indeed, NPR called it “one of the most lobbied health-care bills in recent history,” with lobbyists outnumbering lawmakers on the hill three-to-one.

“I think it’s a very exciting time for the medical device and pharma industry and they were very involved in this as well,” Brooks says.

Indiana Medical Device Manufacturers’ Council Executive Director Kathy Heuer says shortening FDA approval time could mean the difference between life and death.

“If it takes two years in order to get something approved in order to get something on the market,” she says. “Well…a lot of things can happen in that two years if you’re a patient.”

Critics worry speeding up approval would result in less stringent safety standards—a claim the FDA and Heuer dispute.

“It’s not that we’re trying to overlook some of the safety issues,” Heuer says, noting the FDA’s support of the bill. “We want to make sure the FDA process retains its safety protocol.”

The FDA has said even though the approval process is sped up, the agency’s safety standards would remain unchanged.

IUPUI health policy expert Basia Andraka-Christou, who is largely positive about the bill, says critics have accused lawmakers of bowing to big pharma in exchange for more research funds. She says every piece of legislation involves compromise, “but what people are upset about is the compromise is maybe taking too much of pharmaceutical companies’ interests into account.”

Sandwiched in between those initiatives is $1 billion in grants to be used for individual states’ prevention and treatment of opioid abuse. That money could go toward programs such as prescription drug monitoring or health care training.

The funding would be great news for state health officials. Earlier this year, Congress passed a law—the Comprehensive Addiction and Recovery Act—authorizing grants to stem the national drug crisis. However, the bill didn’t authorize significant funds to be used by states to pay for those initiatives.

Brooks says the money in 21st Century Cures could partially go to some of those programs, even though the money doesn’t exactly match up. For example, CARA contains language for federal initiatives, too, and because the 21st Century Cures money is distributed solely to states, it couldn’t be used for that purpose.

Brooks’ office adds the 21st Century Cures cash is allotted specifically for treating opioid abuse, while CARA contains programs that work with a broader spectrum of addition and drug problems.

However, Andraka-Christou says the massive bill does its part to address other issues too.

“Certainly, there are whole sections talking about opioid use disorders specifically, but there’s also many sections that are very broad talking about substance abuse disorders and mental health in general,” she says.

If the Senate gives “Cures” a nod, the funding will still need to clear some hurdles. For example, that billion dollars is discretionary spending, so Congress will need to vote to approve the funding even if the bill is passed.

Brooks says she isn’t worried. “It is such an important priority of members of the House and Senate,” she says. “I don’t anticipate a problem with that receiving the funding that is in this bill.”

Money for 21st Century Cures is accounted for in the bill. In another controversial move, to pay for the research funds and opioid assistance, money has been stripped from a portion of the Affordable Care Act. Tapping a portion of the U.S. Government’s Strategic Petroleum Reserve would supply other funds.

In a rare bipartisan show of support, the bill passed the House 392-26.

The bill is expected to head to the Senate early next week.