The 21st Century Cures Act: A Win for Drug and Medical Device Companies

Defective Drugs
Federal Legislation

By Lynn Shapiro, Staff Writer

Resisting critics who say the law is an early Christmas present to drug and medical device makers, President Obama earlier this month signed the $6.3 billion 21 Century Cures Act.

The legislation is a grab bag of scientific innovations, and a frightening unraveling of FDA approval standards that are intended to boost the bottom lines of pharmaceutical and medical device industries to the detriment of patients.

In an unusual show of bipartisan support, the law, two years in the making, was overwhelmingly passed in the House and the Senate.

Senate Majority Leader Mitch McConnell called it “the most important legislation that Congress will pass this year.”

 Senators Bernie Sanders and Elizabeth Warren are fierce critics of the law.

“It’s time for Congress to stand up to the world’s biggest pharmaceutical companies, not give them more handouts, “Sanders said in a Senate speech.

 Warren also fought the bill “because I know the difference between compromise and extortion.” she said.

The Good News

The $6.3 billion Cures Act includes $4.8 billion earmarked for the National Institutes of Health (NIH).

This funding includes $1.4 billion for President Obama’s Precision Medicine Initiative, using molecular biology, or snippets of DNA and protein, to tailor treatments to individual patients; and another $1.8 billion for Obama’s Moonshot effort to end cancer.

The biological treatments being studied would include the immunosuppressants now used as front-line cancer treatment.

Obama noted that NIH’s Moonshot cancer program had been named in honor of Biden’s son, Beau, who died of brain cancer at age 46, in 2015.

The package also includes $1.6 for Obama’s Brain Initiative, designed to cure dementia and Alzheimer’s disease

 Another $1 billion is provided to oversee new opioid abuse prevention and treatments, a measure Obama strongly endorsed.

A grieving father of a drug addict stood by the President’s side, while he signed The Cure Act into law with his left-handed scrawl earlier this month. He was also flanked by Joe Biden.

The law will also help mentally ill patients and target treatments for suicide, providing Federal hands-on direction to the states, especially in rural states that have limited access to the newest mental health awareness, treatments and facilities.

The law will also advance communications among Electronic Health Records (EHR’s) providers, to better avoid medical errors.

Obama has given doctors incentives to use EHR’s since he assumed the Presidency in 2008.

The Bad News

The law would give $500 million to the FDA to accelerate its approval process for both drugs and medical devices.

Among those healthcare experts battling the FDA portion of the Cure Act are two Johns Hopkins physicians, Reshma Ramachandran and Zackary Berger, who say the law would “unravel the FDA.”

Reshma Ramachandran, MD., is an assistant scientist at the Johns Hopkins Bloomberg School of Public Health and co-chair of the National Physicians Alliance FDA Task Force.

Zackary Berger, MD. Is an assistant professor of medicine at the Johns Hopkins School of Medicine and a core faculty member in the Johns Hopkins Berman Institute of Bioethics.

The doctors write that “as members of the National Physicians Alliance (NPA), we have been closely following the 21st Century Cures Act legislation and its potential impact on what ‘FDA approved’ would mean for new drugs and devices.

“Our interest in the 21st Century Cures Act emerged from overarching concerns … [that] the safety, efficacy, and security of new treatments were not being hijacked by the pharmaceutical and medical device industries.

“The act, for instance, would pressure the FDA to approve new antibiotics, antifungals and possibly other drugs through a new and faster pathway called the ‘limited population antibacterial drug’ pathway.’

“Through this expedited pathway, new medicines would be approved and labeled for use in patients with ‘unmet medical needs’, even though these drugs had never been tested in these specific patient populations.

“The act would also allow for new high-risk medical devices to be approved based on anecdotal case studies or reports in medical journals, rather than having to be held to the gold standard of testing in clinical trials,” the Johns Hopkins physicians wrote.

Devices Monitored by Third Parties

“On top of that, manufacturers would be able to make changes to these high-risk devices without any FDA oversight. Instead, the changes would be monitored by third-party contractors--paid by industry.”

The Hopkins doctors say “health professionals need a way to convey to patients that treatments are safe and effective. The imprimatur of the FDA is current a kind of Good Housekeeping Seal of Approval.

“Weakening FDA’s standards would undermine our trust and leave patients at a loss. Without a strong FDA, who else will let providers and patients know if a treatment will work or is even safe: Pharmaceutical companies? Medical device manufacturers?” the doctors ask.

An Early Christmas Present

Public Citizen’s Health Research Group is another group that has come out against the legislation.

“It is sorely disappointing that Congress gave Big Pharma and the medical device industry an early Christmas present by passing the 21st Century Cures Act,” said Dr. Michael Carome, director of Public Citizen.

“This gift--which 1,300 lobbyists, mostly from pharmaceutical companies--helped sell-comes at the expense of patient safety by undermining requirements for ensuring safe and effective medications and medical devices,” he wrote.

Another formidable critic, Rita Redberg, editor of the journal JAMA Internal Medicine, and a well-known cardiologist at the University of California, wrote,

“In our rush to find new, effective treatments, we should not harm our patients with ineffective, toxic ones.”

Massive Lobbying

“The changes represent a massive lobbying effort by 58 pharmaceutical companies, 24 device companies and 26 biotech companies, according to a Kaiser Health News analysis of lobbying data compiled by the Center for Responsive Politics.

The groups reported more than $192 million in lobbying expenses on the Cures Act and other legislative priorities, the analysis shows.

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