6686dfaf417fe4e9fc9b93da38765075.jpeg

US Senate passes $6.2bn health bill to expedite approval for drugs

21st Century Cures Act took two years to negotiate and boasts broad, bipartisan support, though some critics argued it is part of a deregulatory agenda

The US Senate passed a mammoth health bill on Wednesday that took two years to negotiate and boasts broad, bipartisan support.

The bill is now on its way to Barack Obamas desk. On Wednesday, he said he looked forward to signing it.

We are now one step closer to ending cancer as we know it, unlocking cures for diseases like Alzheimers, and helping people seeking treatment for opioid addiction finally get the help they need, the president said in a statement.

The bipartisan passage of the 21st Century Cures Act is an example of the progress we can make when people from both parties work together to improve the health of our families, friends and neighbors.

Like many bipartisan works, the $6.2bn 21st Century Cures Act is chock full of compromises.

Critics argue it is part of a deregulatory agenda that dilutes high Food and Drug Administration (FDA) standards in return for the unrealized promise of biomedical research funding. High-profile liberal senators, such as the Democrats Elizabeth Warren and Bernie Sanders, and some consumer groups have criticized what they see as giveaways to the pharmaceutical industry.

Proponents call the bills mental health, opioid addiction, and brain and cancer research provisions a boon to public health. Republican backers have heralded the bill as transformational and life-saving, and some not-for-profit groups such as the American Cancer Society have also expressed support.

Patients, doctors and scientists are supporting 21st Century Cures, said the Republican Senate health committee chairman, Lamar Alexander, in a statement on Monday.

The Democratic Colorado congresswoman Diana DeGette called the bill a watershed moment for patients.

Were bringing hope to millions of people suffering from cancer, Alzheimers disease, diabetes and a host of other ailments, she said.

Caitlin Morris, a health system program director at Families USA, a patient advocacy group that has not taken a public position on the bill, said: The intent of the law is to create additional pathways for new drugs to come to market quickly, … That carries both risks and benefits, and I think that is the heart of the contention of this bill.

Expedited approval

Stuffed within its thousands of pages, the 21st Century Cures Act attempts to expedite approval of some drugs and medical devices to the potential detriment of the public, consumer groups argue.

I think the negative concerning features of the bill are pretty substantial, said Aaron Kesselheim, a physician, lawyer and associate professor in pharmacoeconomics at Harvard University. We want innovation that works, and I think what this bill is about is trying to push through new treatments without first ensuring that they work.

One contentious provision, for example, directs the FDA to assess whether new drug uses, or indications, could be approved based on real-world evidence, such as observational studies.

Currently, every indication needs to be approved using the gold standard, a randomized controlled trial, because such trials are considered less biased than observational studies.

Physicians are permitted to prescribe drugs whether or not they are approved for indications other than those on the label, but drug companies cannot advertise the drugs for those uses. Faster approval of new indications could allow drug companies to advertise more quickly, but critics argue it would also create a double standard in terms of determining which drugs should be usedto treat what.

One example of common off-label prescribing is quetiapine, also known as Seroquel, a medication used to treat schizophrenia. It is commonly also prescribed to treat bipolar disorder, though this is not on the label. Stanford University pointed to this drug as one of the most urgently needing study for off-label use.

You are loosening certain restrictions, said Morris. On the one hand, it will get it to market sooner for folks that might benefit sooner, but on the other hand might lower the level of confidence we have on the safety and the efficacy of drugs we have and provide.

Another measure would reclassify some medical devices, instruments permanently implanted in patients, as breakthrough devices.

The last thing we need to do is any further weakening of this process, said Michael Carome, a physician and director of Public Citizens Health Research Group, a consumer advocacy group, referring to medical device approval. Its already too lax. Its already an expedited process, but [the] breakthrough devices [provision in the new bill] would further rush the process and allow smaller clinical trials.

President
Barack Obama has urged the passage of the 21st Century Cures Act. Photograph: Monica Herndon/AP

The bill does nothing to address prescription drug prices, which 77% of Americans said were unreasonable as recently as September, according to the Kaiser Family Foundation.

The Cures Act expands innovation vouchers, a system under which drug companies can receive fast-track status for an application, and which critics have described as broken. Therapies derived from stem cells, called regenerative medicine, are given a push.

Theres already a great deal of quackery in the field, said Carome, referring to regenerative medicine. There are clinicians promoting these as cures for heart disease and Alzheimers They should be subject to the most rigorous standards.

Some measures have, however, won support from influential organizations such as the American Cancer Society and the Mayo Clinic. The bill proposes $1bn in funding for opioid treatment, and $4.7bn for the National Institutes of Health to give more biomedical research grants to scientists. The bill also funds Vice-President Joe Bidens Moonshot cancer research.

But funding for the bill is subject to approval in forthcoming appropriations bills now and for the next 10 years. So each Congress needs to approve the funding.

Some are also concerned that $3.4bn comes from the Prevention and Public Health fund, a pot of cash meant to prevent hospital-acquired infections, chronic ailments, Alzheimers and cancer.

According to an NPR and Center for Responsive Politics analysis, lobbyists arguing for or against the 21st Century Cures Act courted lawmakers to the tune of $192m this year, as nearly three lobbyists for every lawmaker poured into the capital.

Read more: https://www.theguardian.com/us-news/2016/dec/07/mammoth-us-health-bill-aims-to-approve-drugs-faster-but-concerns-linger