Consumer advocates, though, see the new development regulations as a recipe for unleashing drugs and devices that would later prove risky and unhelpful.
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The 21st Century Cures Act, if it clears the Senate, will infuse $8.75 billion into the National Institutes of Health and the FDA to pay for research and clinical trials to work to find cures to diseases like cancer, ALS and Alzheimer’s, as well as rare diseases. “You can’t legislate that away”, Jerry Avorn, a professor of medicine at Harvard Medical School, told the Washington Post. “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”.
On the flip side, the White House, while supportive of much of the 21st Century Cures Act, also expressed sequestration-related concerns, complaining that the bill fails to address the matter. The Senate is working on its own version.
If the package is approved, the money will start to flow in October 2016.
NIH funding has remained relatively static in recent years. Six of Massachusetts’ nine House members have already signed onto the bill.
That said, the bill is not universally loved. “What we don’t need is more drugs approved based on lab tests instead of patient benefit”. And the FDA is completing its evaluations generally inside a 6 to 10 month time frame-which is pretty impressive.
There’s also the question of whether the drug approval process really needs speeding up.
To encourage the development of new antibiotics, the legislation will allow these drugs onto the market sooner to treat people who have no other option and are suffering from a life-threatening illness.
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. It would create incentives for companies to develop drugs for rare diseases.
Perhaps most wonderful of all is that Congress, which has been hopelessly gridlocked over the issues, has reached a point where there could be enough bipartisan support to get a bill like this passed.
Massachusetts drug and device industry groups challenge the notion that the bill would put patient safety at risk.
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Tom Sommer, president of the Massachusetts Medical Device Industry Council, remarked “We’re not asking for anything other than to approve safe and effective devices in a more expedited fashion”. A faster approval process can’t fix a dearth of innovation from labs themselves. “Fast can still be deliberative and conservative”. The authors include House Energy and Commerce Committee Chairman Fred Upton (R-Mich.), and Reps. That funding is offset by selling oil from the Strategic Petroleum Reserve, as well as reforms to Medicaid payments, and delaying reinsurance payments for stand-alone prescription drug plans in Medicare Part D. “The 344 votes today should be a springboard for action”. The group came out strongly against the bill this week because it sidesteps budget caps in place since 2011. It’s “not a piggy bank for lawmakers to use to offset their desire for immediate spending increases”, the group said in a statement.
