President Obama is poised to sign into law the 21st Century Cures Act, a large piece of legislation that he praised over the weekend in his radio address. The bill drastically deregulates the drug approval process, a move that could increase the risk of harm to patients and lead to wasteful spending on drugs that don’t work.
As the Project On Government Oversight pointed out in its latest investigation, which delved into the pharmaceutical industry’s influence on drug regulation, the Cures Act risks patient lives through changes to the Food and Drug Administration’s (FDA) vetting process for drugs. To accelerate the drug approval process, the bill could lower the standards for drug review. Where the FDA has relied on scientific data from controlled clinical trials for the testing of new drugs and medical devices, the Cures Act would pave the way for drug review through “patient experience data” and “real world evidence.” These methods take a lot less time and money than controlled clinical trials but they could amount to little more than anecdotes and marketing spin by drug companies.
The bill would also allow the FDA to rely on summaries submitted by drug companies, instead of the underlying clinical data.
As a result, the legislation could expose the public to drugs that aren’t safe or are ineffective. And, by making it easier for drug companies to market drugs that are neither safe nor effective, it could weaken incentives for those companies to develop better drugs.
We take great issue with approving unproven drugs. Pharmaceutical companies will see profits by selling drugs that do not work, while consumers, government healthcare programs, health insurers, and other stakeholders would waste their money. This could contribute to spiraling healthcare costs and to increasing health insurance premiums.
The last point the President made in his weekly address was that through the legislation, “we’re making sure the FDA incorporates patients’ voices—your voices—into the decisions they make as they develop drugs.”
Unfortunately, patients’ voices can be manipulated by industry and cherry-picked to support drug approvals.
Our investigation showed that, of the dozens of patient advocacy groups participating in stakeholder meetings at the FDA, 93 percent of the groups were funded by drug companies. More than a third of the groups have industry personnel on their boards.
Many of those patient advocacy groups have called on Congress to adopt the Cures Act.
We can’t count on these groups to give voice to the public when they can so easily be a mouthpiece for industry.
Based on our recent investigations into the pharmaceutical industry’s relationships with the FDA and with patient advocacy groups, Congress and the President should have taken a different approach to this legislation.