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Not the Right Antidote for Patients: The 21st Century Cures Act Is Not a Way Forward

July 10, 2015

Not the Right Antidote for Patients: The 21st Century Cures Act Is Not a Way Forward

Statement of Vijay Das, Health Care Policy Advocate, Public Citizen’s Congress Watch Division

Note: Today, the U.S. House of Representatives overwhelmingly voted in favor of H.R. 6, the 21st Century Cures Act.

It is disappointing that the House has passed the 21st Century Cures Act. The bill is a bad deal for patients. It fails to advance scientific innovation and medical breakthroughs, and would undermine our ability to approve safe and effective medications as well as high-risk medical devices.

At its core, this legislation is a horse trade: In exchange for increased funding for the world-renowned National Institutes of Health (NIH), lawmakers added perks for the pharmaceutical and medical device industries. This is unacceptable.

We should not hold NIH funding hostage in the false pursuit of scientific and medical breakthroughs while undermining safety and access to essential medicines and treatments.

The bill lowers standards for U.S. Food and Drug Administration (FDA) approval of medical devices and medications (particularly with respect to antibiotics), scales back the requirements of the Physician Payment Sunshine Act and extends marketing exclusivity for certain pharmaceutical treatments, which would drive up health care costs while making it more difficult for ordinary people to access affordable treatments.

Several proposed amendments would have mitigated some of the damage caused by this bill, but the House Rules Committee did not permit a vote on them.

One rejected amendment (PDF) would have eliminated a provision that undermines medical device safety. Another rejected amendment (PDF) would have limited the coddling of the pharmaceutical industry by striking a provision that extends the time patients must wait for generic versions of medicines to enter the market.

As written, this medication marketing provision would delay patients’ access to affordable, life-saving medicines. The Congressional Budget Office estimates (PDF) that this six-month extension of marketing exclusivity for certain pharmaceutical products would cost the federal government about $869 million between 2016 and 2025. This provision adds costs to the federal budget that would increase over time.

The Senate should not take up this bill, but should instead craft an alternative that restores federal investments in basic science and research while upholding standards to ensure safe and effective treatments are approved for patient use.

The White House issued a statement (PDF) that made mention of our concerns regarding this sweeping deregulatory bill. The president should do more.

The president’s best course of action is to veto the 21st Century Cures Act should it make its way through Congress.