FDA overhaul bill moves ahead after funding deal
Sweeping legislation to overhaul the nation’s drug and device approval process and boost medical research funding raced ahead last week in the House of Representatives.
The House Energy and Commerce Committee voted unanimously Thursday to move the 21st Century Cures Act to the full House for consideration after lawmakers reached agreement on pay-fors for its estimated $13 billion cost over 10 years. “Every single member here on both sides of the aisle has something in this bill,” said committee chairman Fred Upton (R-Mich.).
The bill would provide more than $10 billion over five years to the National Institutes of Health, as well as $550 million in added funds to the Food and Drug Administration to help it handle the revised approval process.
Senate leaders plan to craft their own biomedical innovations bill, though they say it won’t be ready until the fall at the earliest.
Lawmakers were worried about potential cuts to Medicare and Medicaid to offset the bill’s costs. Instead, lawmakers agreed to fund the bill from the sale of crude oil from the Strategic Petroleum Reserve, as well as from limiting Medicaid rates for some durable medical equipment to Medicare rates.
The deal also would alter the timing of reinsurance payments to Medicare Part D prescription drug plans to reduce accrued interest. America’s Health Insurance Plans opposes that provision.
A congressional aide said on background that a detailed estimate of how much money each pay-for would generate will come in a few weeks.
Supporters say the Cures Act would speed life-saving innovations in drugs and devices. Critics argue that the bill would heighten the risk for patient harm by loosening approval standards and that it could increase healthcare spending for products of marginal value.
A key provision would allow the FDA to grant market approval for a drug based on early stage testing for safety and effectiveness.
Devicemakers would be able to apply for a “breakthrough designation” pathway for products that treat conditions where no alternative exists or that significantly improve on existing therapies.
The FDA also would be required to establish a process for the use of surrogate markers in clinical trials, cutting the time needed for getting results from drug trials.
A controversial proposal to lengthen market exclusivity for some new medications was significantly scaled back. In addition, language to tighten controls over the 340B program giving hospitals serving low-income and uninsured patients a discount on drugs was removed.