Controversy Surrounds Passage of 21st Century Cures Act

Legislation could significantly accelerate the FDA drug approval process.

Last week, the House of Representatives passed the updated version of the 21st Century Cures Act.

The updated version of the law was released in November, and includes many of the previous version’s provisions. The law that was passed now includes allocation of federal funds to mental healthcare services, as well as the prevention and treatment of opioid use disorder.

In July 2015, the previous version of the law was passed by the House, but the initiative did not pass in the Senate. The Senate started to combine existing bills into a smaller package to parallel the effort, but the legislation was never voted on, according to a report by Avalere Health.

The updated version of the 21st Century Cares Act also incorporates a novel method of paying for the bill, since President-elect Donald Trump has suggested at least a partial repeal the Affordable Care Act (ACA), which leaves new ways to pay for the legislation.

The bill would reduce funding to both the FDA and the National Institutes of Health, with the FDA’s funding getting cut from $550 million to $500 million, and the National Institutes of Health’s funding getting cut from $9.3 billion to $4.8 billion. However, the funding for certain initiatives, such as precision medicine and brain research, will remain intact.

The updated law would grant $1 billion to states for the prevention and treatment of opioid use disorders, which has placed a great burden on the United States in the recent past. It will also provide funding for mental health and family services, according to Avalere.

Additionally, the bill will fund research related to regenerative medicine, antimicrobial, and medical countermeasures.

A majority of funding for this novel bill will come from the Strategic Petroleum Reserve (SPR) and other funding allocated to the ACA’s Prevention and Public Health Fund, Avalere reported. Further funding will come from payment changes for Medicare and Medicaid.

“A Trump presidency increases the probability of funding this bill by using money allotted for the ACA and enacting a SPR drawdown,” said Jay Jackson, a manager at Avalere Health. “Although Cures has always had broad bipartisan support, a different political environment also improves the chances that the package will make it through the Senate. While the timing of this vote is uncertain, they are pushing for this year.”

Despite the bill passing in the House, many Senators have expressed opposition to the bill. Senator Elizabeth Warren (D-MA) has previously made remarks about the 21st Century Cares Act during a floor speech.

Sen Warren said that exit polls indicated that 70% of voters felt that the economy and lawmakers were owned by big companies, including those in the pharmaceutical industry.

“When American voters say Congress is owned by big companies, this bill is exactly what they are talking about,” she said during the speech. “Now, we face a choice. Will this Congress say that yes, we're bought and paid for, or will we stand up and work for the American people?”

The bill would significantly reduce funding to the National Institutes of Health, which has achieved numerous medical breakthroughs, with many of these breakthroughs for cancer treatments. The bill would also increase the speed at which the FDA approves certain drugs, and has the potential to harm patients.

If the 21st Century Cures Act is implemented, the bill will prevent finding cures for serious diseases, Warren argued. She also said that this bill will legalize fraud, cover up bribery, and hand out deals to Republican campaign contributors.

During the speech, she called for other Democratic lawmakers to stand up and fight the passage of the bill, since it could prevent medical advances, and may cause harm to patients taking medications that were approved by an underfunded FDA, that would be working towards faster approvals instead of focused on safety.

“I will work for the hundreds of thousands of scientists and doctors who are committed to saving lives and who are waiting for Congress to fund their work. I will work for the millions of families that have been touched by Alzheimer's, diabetes, cancer, and other deadly diseases who are counting on that research,” Warren concluded. “I will work for the 70% of voters who are sick of a Congress that is owned by big donors and giant corporations.”