The bill also aims to modernise and accelerate the FDA's current approval process, which delays potentially lifesaving drugs and devices from reaching patients who need them, boost funding for research, and get cures onto the market at a faster rate.
Patient advocacy groups, drug and device companies, and more than 1,400 lobbyists have pushed for the bill's passage - even more so in recent years. The House then overwhelmingly approved it, defying critics who said the bill was too heavily influenced by the pharmaceutical industry.
An earlier version of the Cures Act passed the House but failed in the Senate in July 2015. It has been revised since and the latest version has been swiftly approved in the lame-duck session. But is it really beneficial?
Bill might weaken FDA's authority, compromising patient safetySenators Bernie Sanders and Elizabeth Warren were both strongly against the bill.
"It's time for Congress to stand up to the world's biggest pharmaceutical companies, not give them more handouts," Sanders said in a statement. In a Senate speech last month, Warren also vowed to "fight [the bill] because I know the difference between compromise and extortion."
There is much evidence that supports their fight. Researchers studying the FDA have repeatedly pointed out that some provisions weaken the FDA's authority and potentially compromise patient safety. This makes it easier for companies to bring substandard or ineffective medicines and devices to market.
Rita Redberg, editor of the journal JAMA Internal Medicine, wrote that it could amount to a dangerous trade-off: "In our rush to find new effective treatments, we should not harm our patients with ineffective toxic ones."
Accelerating the world's fastest regulatory systemThe FDA is already the fastest regulatory system in the world, with several expedited approval pathways for important drugs, compared to the 1980s. However the number of new drugs surfacing on the market has dropped to historical averages.
Many pharmaceutical companies still think that the FDA is not fast enough. As Harvard's Aaron Kesselheim said, "There are a lot of powerful financial interests that would like to see reduced hurdles toward getting their products on the market because it can be expensive to run tests to show that your product works."
A third of new drugs are currently approved on the basis of a single pivotal trial - with a median size of 760 patients. More than two thirds of new drugs are approved based on studies lasting six months or less - which could be hazardous for medications that are designed to be taken for a lifetime. The FDA then takes six to ten months to review the drug - an short turnaround rate for such complex assessments.
Trading transparency and solid evidence for accelerated approvalThe bill also allows drug makers to put forward "real-world evidence" to support the approval of a new indication (or use) for an existing drug or for a new drug that was approved through an accelerated regulatory pathway. Previously, only rigorous clinical trials are allowed.
"This raises all sorts of red flags to me. You don't know 100% how well something works unless you're studying it in a trial," said Joseph Ross, a Yale researcher who has been studying the FDA.
Drug companies are also allowed to submit "summary-level reviews" for new indication approvals, in addition to raw data, which are currently compulsory for submission in the FDA process. However researchers think the resource-starved FDA may take advantage of this and make decisions based on the potentially biased summaries - created by pharmaceutical companies - instead of investigating the data themselves.
"This undermines the integrity of the regulatory review process, and it limits transparency," Ross said. "In today's day and age, we're moving toward greater transparency, more access to data, more data sharing."
Hidden conditions behind funds for medical research and mental health issuesFor medical research, mental health issues and the opioid crisis, the bill brings some benefits - it increases much-needed funding for the National Institutes of Health (NIH) with USD4.8 billion over 10 years, USD500 million for the FDA, USD1 billion for state governments to battle the drug abuse epidemic, funds mental health services on university campuses and expands Medicaid to children with severe mental illnesses.
However, the NIH will only get their funds if future Congresses sign off on appropriating them - the bill is also paid by cutting USD3.5 billion from public health spending.
"There are lots of good things in the bill," Ross said, "but they are all bungled together with things that undermine the FDA's regulatory authority." MIMS
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