The FDA Reauthorization Act (FDARA) of 2017 sailed through a final Senate vote of 94-1 despite a drawn-out cloture vote. The upper chamber passed three other bills along with the latest user fee legislation, including a bill that would require the Department of Health and Human Services (HHS) to develop a standard for "prominently displaying" information related to a patient's opioid addiction history in electronic health records (EHRs).

The vote for cloture of debate for H.R. 2430 came to 96-1, with Vermont independent Sen. Bernie Sanders serving as the lone holdout. H.R. 2430 as voted on in the Senate retains provisions relating to medical device inspections and over-the-counter hearing aids, as well as text dealing with reviews of generic drugs. The bill requires that the Government Accountability Office report to Congress annually on the state of the FDA's facility maintenance and renovation, and appears to attempt to get around the fungibility problem by stipulating that user fees cannot be used for facilities or for the acquisition of scientific equipment unless that equipment is deemed "necessary scientific equipment." Whether that leaves the agency free to use industry fees to purchase or upgrade information technology used in product reviews is not clear.

President Donald Trump is expected to sign the user fee bill into law, even though his proposed budget called for increasing the fees to fund the entirety of the FDA's review operations. The president reiterated that desire last month. However, HHS Secretary Tom Price said Congress "is to be commended for passing the FDA Reauthorization Act of 2017" in a statement posted to the department website after the Senate vote.

Price said nothing about the question of user fees vs. appropriations, characterizing H.R. 2430 as "a vital first step to accomplishing our goal of expanding access to affordable, life-saving drugs and medical devices in a thoughtful manner that protects taxpayer resources, promotes competition, improves health care outcomes, and stimulates scientific innovation and medical advances." Beyond that, Price said only that the administration would work with FDA Commissioner Scott Gottlieb to "ensure that FDA remains the gold standard in advancing medical breakthroughs that will improve the health and well-being of the American people."

FDARA was posted to the White House website Monday and listed as pending.

Industry enthused, watchdogs unimpressed

The reaction to the vote was immediate, with the trade associations generally supportive of the vote, but Danielle Brian, executive director of the Project on Government Oversight said, "Congress should have hit the pause button instead of fast-tracking" the legislation.

Brian decried the bill's provision that device malfunctions would not have to be as promptly reported as adverse events, asserting that patients "could be left in danger as malfunctions mount." She said the agency negotiated the deal "with a budgetary gun to its head," and that the prominence of user fees in the agency's budget suggests that industry lobbyists have "extraordinary sway over how the agency does its job."

Peter Maybarduk, of Public Citizen, said the exclusion of the Orphan Products Extension Now (OPEN) Act from the user fee reauthorization is a case of "saying no to the pharma lobby and to longer, exorbitantly priced monopolies on medicines, and saying yes to the American people." Maybarduk said three of four Americans "favor shortening the length of monopoly granted on prescription drugs," and urged passage of two bills aimed at drug pricing, including the Stop Price Gouging Act (S. 1369).

Mark Leahey, president and CEO of the Medical Device Manufacturers Association, said the device user fee program "has a proud history of bipartisan and broad input from policymakers and stakeholders, which was reflected by the Senate's overwhelming vote to reauthorize" device user fees. Leahey said patients and providers "have always been the true beneficiaries of this program as it continues to seek improvements and efficiencies that ultimately result in better health care and outcomes."

Steve Ubl, president and CEO of Pharmaceutical Research and Manufacturers of America, said the new drug user fee agreement "better incorporates real-world evidence and patient perspectives into the drug development and approval process," and provides the FDA "with new tools and resources to keep up with the latest scientific advances." Ubl said pharmaceuticals will consequently arrive in pharmacies more quickly and that enhanced competition will lower costs.

Scott Whitaker, president and CEO of the Advanced Medical Technology Association, said the new user fee agreement represents "a victory for the agency, innovation and, most importantly, patients." Whitaker cited the bill's provisions for the FDA inspections process as positives, adding, "We urge the president to move swiftly in signing the bill into law."

Joe Robinson, chairman of the Medical Imaging & Technology Alliance, said the bill "clarifies the FDA's authority to continue to consider and clear new indications for imaging device manufacturers, while providing contrast agent manufacturers with incentives to update contrast agent labels" for previously approved products. Robinson noted that the bill omits language dealing with third-party imaging service companies, stating, that as matters stand, "only medical device service activities performed by a manufacturer are regulated by the FDA," a predicament he said could "put the patient at risk for serious physical injury or result in low image quality."

Jim Greenwood, president and CEO of the Biotechnology Innovation Organization, said the reauthorization of the biosimilars user fee program "will create a more robust and competitive marketplace for biosimilar therapies, following an appropriate period of exclusivity for innovator biologic products." Greenwood stated further that H.R. 2430 will speed generics to market, thus controlling costs via competition, provisions he said "are consistent with proposals endorsed by BIO to drive smarter spending within our health care system without harming incentives for innovation."

Opioid/EHR bill headed for House

On the day of the FDA user fee vote, the Senate unanimously agreed to three other pieces of legislation without a voice vote, one of which was Jessie's Law (S. 581), authored by Sen. Joe Manchin (D-W.Va.). That bill requires HHS to issue standards that would increase the visibility of any information related to opioid addiction in EHRs.

The bill stipulates that any such information must have been provided by the patient, but it is not clear under what circumstances publishers or purchasers of those programs would be required to include such features in their EHR systems. S. 581, which has been forwarded to the House of Representatives, requires that an advisory panel, which is to include a "patient with a history of opioid use disorders," be convened to discuss those standards.

The Benefit Act of 2017 is a two-page bill that would increase the inclusion of patient information in the FDA's review of premarket filings for pharmaceuticals. S. 1052 would require that the FDA document how patient information was used to inform the agency's benefit-risk assessment of a drug application. Skopos Labs, of New York, an artificial intelligence legislation prediction firm, gives S. 1052 a 30 percent chance of enactment, the same odds Skopos gives S. 581.

The third bill, S. 204, the Trickett Wendler Right-to-Try Act of 2017, is essentially a duplicate of a bill by the same name that failed to gain traction in 2016. The bill's author, Sen. Ron Johnson (R-Wisc.), said similar laws have passed in 37 state legislatures, adding that the subjects of the bill "are real people facing their mortality with no hope." Johnson said the bill had the backing of several Democrats and 43 GOP co-sponsors, including majority leader Mitch McConnell (R-Ky.). That bill also heads to the House with a predicted probability of enactment of 30 percent.

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