Accusations it includes fraud, bribery, corruption; requires Senate passage during lame duck session

By Allen Payton

On Wednesday, November 30, the U.S. House of Representatives passed the 21st Century Cures Act (H.R. 34) on an overwhelmingly bipartisan vote of 392-26. The almost 1,000-page bill is designed for medical innovation, additional funding for cancer research, and to combat the nation’s growing opioid and heroin epidemic. But opponents say what the bill includes continues and advances corruption. Plus, they don’t like the fact it’s being considered and voted on by a lame-duck Congress, some of whose members weren’t re-elected in November and will be leaving, soon.

Congressman DeSaulnier (D, CA-11), who represents most of Contra Costa County and voted for the bill, issued the following statement lauding its passage.

“This legislation will help ensure the National Institutes of Health (NIH) have the resources needed to continue important work improving biomedical research and developing innovative treatments. Included in the bill is funding for the Vice President’s Cancer Moonshot, which is essential to continuing the program under the new Administration, as well as funds to combat the growing opioid and heroin epidemic facing our country. While this bill is not perfect, it provides $4.8 billion in new funding to ensure NIH is able to further its work for patients and families relying on research, treatment and recovery options. As a survivor of cancer and a beneficiary of the remarkable progress this country has made in treatment and research, I know all too well the value of these investments and how many lives can be saved as a result.”

According to other news reports, the legislation was introduced by Rep. Fred Upton, R-Michigan and Rep. Diana DeGette, D-Colo., “in hopes of speeding up the discovery, development and delivery of life-saving drugs and devices for diseases such as cancer, Alzheimer’s and diabetes. It passed the House 344-77 in July, but later stalled in the Senate. A reworked version was released last weekend.”

Congressman DeSaulnier offered an amendment to the bill, which would have helped improve doctor-patient communication when patients are diagnosed and receiving treatment for severe or chronic diseases. No amendments were included in the final version of the bill. He will continue to work on these important issues.

White House Supports

The bill will now go to the Senate for a final vote and if passed the White House has indicated President Obama will sign it. In a statement, issued Wednesday, White House Press Secretary Josh Earnest praised the passage of the bill.

“This critically important legislation will get states the resources they need to fight the heroin and prescription opioid epidemic. It invests the $1 billion the President has repeatedly said is necessary to help communities that have seen far too many overdoses. It also responds to the Vice President’s call for a Moonshot in cancer research by investing $1.8 billion in new resources to transform cancer research and accelerate discoveries. Plus, it invests nearly $3 billion to continue the President’s signature biomedical research initiatives, the BRAIN and Precision Medicine Initiatives, over the next decade to tackle diseases like Alzheimer’s and create new research models to find cures and better target treatments.

H.R. 34 also takes important steps to improve mental health, including provisions that build on the work of the President’s Mental Health and Substance Use Disorder Parity Task Force. It further advances the drug approval process by taking steps like modernizing clinical trial design and better incorporating patients’ voices into FDA’s decision-making processes. Like all comprehensive legislation, the bill is not perfect, and there are provisions the Administration would prefer were improved, but the legislation offers advances in health that far outweigh these concerns. The Senate should promptly pass this bill so that the President can sign it.”

Liberal Opposition

However, not everyone in the Senate is supportive of the bill, including DeSaulnier’s fellow Democrat, Senator Elizabeth Warren (D-Mass). She has been generally supportive of the legislation, but will now work against its passage, blasting it for being favorable to the pharmaceutical industry, saying “there’s a lot of bad stuff” in the bill, and called it extortion, and includes “special favors for campaign donors and giveaways to the richest drug companies in the world.”

In a floor statement on Monday night, which can be viewed here, she said that “Big Pharma hijack(ed) the Cures bill. This final deal has only a tiny fig leaf of funding, for NIH and for the opioid crisis. And most of that fig leaf isn’t even real. Most of the money won’t really be there unless future Congresses passes future bills in future years to spend those dollars.”

Warren continued, saying “In the closing days of this Congress, Big Pharma has its hand out for a bunch of special giveaways and favors that are packed together in something called the 21st Century Cures bill.

And when American voters say Congress is owned by big companies, this bill is exactly what they are talking about. 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?

Medical breakthroughs come from increasing investments in basic research. Right now, Congress is choking off investments in the NIH. Adjusted for inflation, federal spending on medical research over the past dozen years has been cut by 20%. Those cuts take the legs out from under future medical innovation in America. We can name a piece of legislation the “cures” bill, but if it doesn’t include meaningful funding for the National Institutes of Health and the Food and Drug Administration, it won’t cure anything.”

Her reasons for opposing the bill include her argument that “this funding is political cover for huge giveaways to giant drug companies.” She stated it would “legalize fraud” and “cover up bribery,” and, in her usual practice of partisan attacks, also said it would “hand out dangerous, special deals to Republican campaign contributors.”

Warren said that “this Cures bill that would shoot holes in the anti-fraud law. Make it easier for drug companies to get away with fraud.”

Another accusation she made is “the Cures act offers to sell government favors. It delivers a special deal so people can sell…treatments without meeting the FDA gold standards for protecting patient safety and making sure these drugs do some good.”

Warren gave a list of other reasons she opposed it.

“The Cures Act – a bill that was supposed to be about medical innovation – has a giveaway to the gun lobby,” she said. “The bill cuts Medicare funding. It raids money from the Affordable Care Act. It takes health care dollars that should have gone to Puerto Rico. It makes it harder for people with disabilities to get Medicaid services. There’s a lot of bad stuff here.”

“It is time for Democrats – Democrats and Republicans who should be ashamed by this kind of corruption -to make it clear who exactly they work for. Does the Senate work for big pharma that hires the lobbyists and makes the campaign contributions or does the Senate work for American people who actually sent us here,” Warren concluded.

Conservative Opposition

Some conservatives are also opposed to the bill, but not all for the same reasons as Warren’s. The conservative Heritage Foundation gave four reasons they oppose the bill, calling it a “Christmas Tree, loaded with handouts for special interests.”

On their website, they wrote, “Congress has taken this legislation, which was initially a 300 page bill, and turned it into an almost 1,000 page omnibus health care spending bill. The negotiators have added pieces of a mental health bill, makes changes to Medicare Part A and B, another bill making significant changes to the federal foster care system, a “cancer moonshot” requested by Vice President Biden, additional funding for opioid abuse prevention, etc., in addition to the NIH funding and the FDA funding, for a grand total of over $6.3 billion dollars. In Washington terms, backroom negotiators have turned the Cures bill into a Christmas Tree, loaded with handouts for special interests, all at the expense of the taxpayer.  Therefore, conservatives should oppose the 21st Century Cures Bill for four main reasons.

First, the bill’s “pay-fors” rely on budget gimmicks, and even worse, the new spending is not subject to the budget caps. Second, NIH and FDA do not need additional funding. Instead, they need to spend the money they already have on critical research instead of wasteful projects. Third, Congress has no business considering an almost 1,000 page omnibus health care spending bill during the lame duck session. Fourth, and finally, the process has been questionable and the bill will likely be closed to amendments.

An email to DeSaulnier’s office asking for his comments on Warren’s statements opposing the bill was not responded to before publication time. Please check back later for any updates.

A vote by the Senate on the bill is expected to take place early next week. For the complete text of the bill, please click here.