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H.R. 2430: FDA Reauthorization Act of 2017

On Passage of the Bill in the Senate

Bill Passed · Aug 3, 2017 at 12:35 p.m. ET · Source: senate.gov

This was a vote to pass H.R. 2430 in the Senate. The federal budget process occurs in two stages: appropriations, which set overall spending limits by agency or program, and authorizations, which direct how federal funds should (or should not) be used. Appropriation and authorization provisions are typically made for single fiscal years. A reauthorization bill like this one renews the authorizations of an expiring law.

Although health care is one of the most partisan political subjects, a new health care law was just signed with almost unanimous support. The FDA Reauthorization Act of 2017 aims to lower prescription drug prices, amid skyrocketing health insurance costs.

What the law does

The law is an amalgamation of provisions from at least eight different standalone healthcare-related bills which had been introduced earlier this year from both parties. Among its most notable provisions:

  • Reauthorizes so-called “user fees” to the Food and Drug Administration for five years. These fees are paid for by medical drug and device manufacturers with every new product application, and will account for $8 billion over the next five years, or about a quarter of the FDA’s total budget. President Trump actually wanted the FDA funded 100 percent by user fees, as a way of keeping the agency funded while slashing the taxpayer-funded portion, but that plan was rejected by Congress for now.
  • Allows certain types of hearing aids to be sold over the counter. An estimated five-sixths of Americans with hearing loss don’t get hearing aids, in large part because the devices are so expensive. The provision passed over the opposition from an unlikely but powerful source: gun rights groups, which claimed the provision could allow the FDA to regulate sound amplification devices often used by hunters. (It wouldn’t.)
  • Requires the FDA speed up approval process for many types of generic drugs. The sped-up process would be invoked if a similar medication is being sold at an “egregious” price. That could mean huge savings for consumers and taxpayers, as generic drugs usually cost about 80 to 85 percent less than their name-brand competitors.
  • The Right to Try Act was separately passed by the Senate. This would allow the terminally ill to access experimental drugs and medications prior to FDA approval, a process which can normally take years. Although that’s a separate bill, Senate lead sponsor Ron Johnson (R-WI) threatened to hold up the entire FDA Reauthorization Act — which he otherwise supported and ultimately voted for — unless his own languishing Right to Try Act received a separate vote in the Senate. It passed with unanimous consent, and now awaits a vote in the House. If enacted, it would be as standalone legislation, not as a component of the FDA Reauthorization Act.

What supporters and opponents say

Supporters argue the law will lower costs and keep the FDA in line with the changing times.

The law “is ensuring that safe and effective, life-saving treatments will continue to reach American patients, from innovative new drugs, to generic drugs, biosimilars, and medical devices,” Secretary of Health and Human Services Tom Price said in a statement. “The law will support our team at FDA as they carry out the HHS mission to enhance and protect the health and well-being of the American people and continue to advance medical breakthroughs.”

Only former presidential candidate Sen. Bernie Sanders (I-VT) voted against the bill in the Senate.

Sanders believed the legislation “does nothing to lower drug prices and is a giveaway to the pharmaceutical industry,” a spokesperson told Axios. He also protested the Senate’s rejecting a provision he proposed for the bill, which would have allowed Americans to more easily purchase or obtain medications from Canada, where costs are noticeably less expensive.

The last time the reauthorization of FDA fees passed passed was in 2012, and Sanders was the only Senate opposer then too.

Votes

It passed the House on July 12 by voice vote, meaning there was no significant opposition and no record of individual votes was cast. The bill was introduced by Rep. Greg Walden (R-OR2), Chairman of the House Energy and Commerce Committee.

It then passed the Senate on August 3 by 94–1, with the aforementioned Sen. Sanders opposing, after being introduced by Sen. Lamar Alexander (R-TN).

President Donald Trump signed the current version into law on August 18. It was introduced in the House as H.R. 2430 and the Senate as S. 934, but is now designated Public Law 115–52.

Totals

All Votes R D I
Yea 94%
 
 
 
94
47
 
46
 
1
 
Nay 1%
 
 
 
1
0
 
0
 
1
 
Not Voting 5%
 
 
 
5
5
 
0
 
0
 
Simple Majority Required

Ideology Vote Chart

Key: R Yea D Yea
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Statistically Notable Votes

Statistically notable votes are the votes that are most surprising, or least predictable, given how other members of each voter’s party voted and other factors.

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