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FDA bill advances after House lawmakers drop 'off-label' communications pursuit

After an all-day hearing on June 7, the House Energy and Commerce Committee voted unanimously to advance a must-pass bill to renew four user-fee programs that the U.S. Food and Drug Administration relies on for more than half of its funding.

But that 54-0 vote did not come without long discussions over the rising costs of medicines and making it easier for drug and device manufacturers to discuss unapproved, or "off-label," uses of their products with payers, healthcare providers and other potential stakeholders.

While part of the mark-up hearing involved voting on 11 energy-related bills, most of the session revolved around passing the Food and Drug Administration Reauthorization Act of 2017, or FDARA.

The Energy and Commerce Health Subcommittee already had added amendments to the bill on May 18.

But lawmakers offered up more than a dozen other measures during the June 7 hearing, two of which posed a potential threat to the FDA bill advancing to the House floor.

Rep. Greg Walden, R-Ore., chairman of the Energy and Commerce Committee, noted that if Congress does not complete its work on the FDARA bill and have it to President Donald Trump's desk before lawmakers depart for their August recess, "not only will thousands of FDA employees be seeking new employment, but desperately needed treatments and cures will not reach patients."

"We cannot and will not stand for that," Walden declared.

The bill, which would renew the FDA's authority to collect user fees from makers of prescription brand-name drugs, medical devices, generic medicines and lower-cost versions of biologics, or biosimilars, easily sailed through the Senate Health, Education, Labor and Pensions Committee on May 11, although the legislation has yet to be scheduled for a vote in the full chamber.

Rep. Frank Pallone, D-N.J., ranking member on the committee, noted the user fee bills "have always been approved in a strong, bipartisan fashion."

"I'm hopeful that tradition will continue again this year so the medical product review process will continue uninterrupted," he said.

But Pallone and other Democrats, including Sen. Patty Murray of Washington, the ranking member on the Senate HELP Committee, earlier raised other concerns that a proposal from the Trump administration to make industry pay 100% of the costs of drug and device application reviews, could impede the efforts to get the FDA bill across the finish line in time.

Currently, user fees cover just over half of those expenses.

Communicating unapproved uses

While drug prices consumed much of the discussion at the House Energy and Commerce hearing, it was two amendments that aimed to permit manufacturers to talk more broadly than current guidelines allow about off-label uses of their medical products that threatened to derail the FDA bill.

One of the amendment authors, Rep. Brett Guthrie, R-Ky., insisted that if the U.S. was seeking to move to a more value-based system, "timely and robust communication" between medical product developers, payers and others was "more important now more than ever."

Guthrie said payers needed information at least 12 to 18 months before drugs and devices are approved by the FDA so they can make better decisions about covering the therapies.

He argued the audiences the medical product manufacturers would be communicating with would be "sophisticated" enough to understand the limitations of the information about the unapproved products.

But Pallone asserted the amendments from Guthrie and Rep. Morgan Griffith, R-Va., would "blow a hole in the current approval process by allowing the communication of any scientific evidence or healthcare economic information to payers or formularies without any recourse for the FDA to prevent bad actors from communicating false or misleading information."

"It would also hamstring the FDA from considering the product from being misbranded," Pallone added. "Broadening communication this way would undermine the FDA's regulatory review process as well as the safety and effectiveness approval standard, which is the gold standard across the globe."

Erosion of the FDA's standards would harm the public's trust and confidence in the agency's ability to ensure products are safe and effective, he said.

Pallone noted that once a product is on the market, doctors can prescribe it for any use they see fit.

Encouraging communication about unapproved uses or products also would reduce the incentives for companies to conduct studies to pursue approval of additional indications for therapies already on the market, he said.

Before voting on the Guthrie and Griffith amendments, Pallone said the committee should first undertake a thorough examination and have a robust dialogue, "not rush a proposal through in the dark of night."

Griffith and Guthrie agreed to withdraw their amendments after gaining assurances from Pallone that Democrats would work with them to iron out any disagreements, allowing the vote on the FDA bill to move forward.