Health Letter, October 2015
Sarah Sorscher, J.D., M.P.H
Increasingly few Americans are old enough to remember the lax government regulation of drugs and medical devices in the early 20th century, when sellers of “miracle cures” used testimonials to tout their wares and needed to show no systematic proof of safety or effectiveness.
That era ended in 1962, when use of the drug thalidomide in other countries led to birth defects in thousands of babies worldwide and prompted Congress to amend the Federal Food, Drug and Cosmetic Act. In this new era of drug regulation, the Food and Drug Administration (FDA) was given the authority to require that new drugs (and, later, certain high-risk medical devices) be proven safe and effective through rigorous clinical trials.
More than 50 years later, some members of Congress want to drag medical product regulation back in time with the ironically named 21st Century Cures Act. “It’s a bad deal for patients,” said Vijay Das, health care policy advocate for Public Citizen’s Congress Watch division. “The 21st Century Cures Act is a grab bag of goodies for Big Pharma and medical device companies, and would lower FDA safety standards, increase health care costs and endanger public health.”
Pressing for weaker FDA oversight
The 362-page bill, sponsored by Reps. Fred Upton (R-Mich.) and Diana DeGette (D-Colo.), would roll back many of the safeguards established in 1962 and refined over decades.
Some of the bill’s most dangerous provisions attack the FDA’s requirements for proving effectiveness and would make it harder for the FDA to require companies to submit randomized, controlled trials — the gold standard for medical research — for approval of new drugs or medical devices. The bill would pressure the FDA to approve new high-risk medical devices based only on case studies published in medical journals (essentially, medical anecdotes). Companies also could make changes to even the highest-risk devices, such as brain stents and hip implants, without notifying the FDA.
To speed approval of antibiotics and antifungals, the legislation would lower the bar for clinical testing, leading to cheaper, faster and less informative trials. Approval standards already are dangerously low for these drugs, with many risky antibiotics rushed too quickly through the approval process. Two of the antibiotics approved by the FDA in the past decade, bedaquiline (Sirturo) and tigecycline (Tygacil), remain on the market in spite of the fact that they have been shown in clinical testing to increase the risk of death., The 21st Century Cures Act would lower standards for approval even further, practically guaranteeing that the FDA will approve more deadly antibiotics.
More corporate influence and perks
Other harmful provisions of the 21st Century Cures Act would gut the Physician Payments Sunshine Act, which requires pharmaceutical and medical device companies to report payments made to physicians and teaching hospitals. Payments that should be reported under the act — such as speaker fees and covered costs for expensive “medical education” conferences at high-end resorts — would not have to be disclosed. Drug companies use these giveaways to influence doctors and their prescribing habits.
The legislation also offers pharmaceutical companies six months of additional monopoly protection in cases where a drug is newly approved to treat a rare disease, a provision that likely would be subject to rampant abuse and result in increased health care costs. The six-month extension would apply to treatments not only for the rare condition but also for any common condition treated by the drug, which could dramatically boost drug company profits.
Lobbying and ransomed NIH funding
In spite of these harmful provisions, the House of Representatives passed the bill on July 10 — thanks in part to heavy lobbying. Drug and medical device companies spent lavishly on both Democrats and Republicans in Congress in the year leading up to the bill’s passage. In 2014, more than $3.6 million in direct campaign contributions went to House members alone. The largest amount was contributed to the campaign of Upton, one of the bill’s primary co-sponsors.
Also making the legislation more appealing — even for lawmakers who otherwise might be troubled by its impact on patient safety — is the fact that it includes a 5 percent increase in funding for the National Institutes of Health (NIH). NIH finances much of the early-stage basic research in the country, contributing to important medical breakthroughs that lead to revolutionary cures.,
But this 5 percent bump barely scrapes the surface of the immense need at NIH, the budget of which has declined by more than 20 percent since 2004, after adjusting for inflation. Further, the 21st Century Cures funding would expire after just five years.
A fully informed Congress
Public Citizen — acting alone and in a coalition with seven other groups representing consumers, physicians, researchers and public health experts — outlined the bill’s harms to members of Congress as it worked its way through the House this spring.
Some of the worst provisions were taken out. For example, the bill no longer contains a measure that would have significantly extended patent protection for a broad category of new drugs, dramatically increasing health care costs. Such a proposal would have had a more damaging impact on drug prices than the six-month extension mentioned above. Yet many dangerous provisions remain.
To inform the Senate — which is moving more slowly on its version of the bill — a Public Citizen policy expert made a presentation in April before a group of Senate staff members researching medical innovation. The Public Citizen expert cautioned against attempts to accelerate the FDA approval process by lowering safety standards.
Public Citizen has urged Congress to adopt more effective legislation, such as the HEAL Act, which addresses the rising threat of antibiotic resistance. The group also has advised Congress to craft alternative legislation that would restore federal investments in basic science and research while upholding standards to ensure safe and effective treatments for patients.
“Congress should properly address the challenges that lie ahead, not cater to special interests that could put people’s lives at risk,” Das said. “Instead of moving us forward, the 21st Century Cures Act, as written, pulls us back.”
 Food and Drug Administration. Kefauver-Harris amendments revolutionized drug development. October 10, 2012. http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm322856.htm. Accessed September 18, 2015.
 The 21st Century Cures Act of 2015 (H.R. 6). https://www.gpo.gov/fdsys/pkg/BILLS-114hr6eh/pdf/BILLS-114hr6eh.pdf. Accessed September 18, 2015.
 Food and Drug Administration. FDA news release. December 31, 2012. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm333695.htm. Accessed September 18, 2015.
 Food and Drug Administration. Tygacil (tigecycline): Drug safety communication – increased risk of death. September 27, 2013. http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm370170.htm. Accessed September 18, 2015.
 OpenSecrets.org. Pharmaceuticals/Health Products: Top Recipients. http://www.opensecrets.org/industries/recips.php’ind=h04&cycle=2014&recipdetail=H&mem=N&sortorder=U. Accessed September 18, 2015.
 Committee on Energy and Commerce. The 21st Century Cures Act (HR 6). http://energycommerce.house.gov/sites/republicans.energycommerce.house.gov/files/114/Cures2015FACTSHEET.pdf. Accessed September 18, 2015.
 Federation of American Societies for Experimental Biology. NIH Research Funding Rebounds in President’s FY 2016 Budget. http://www.faseb.org/Portals/2/PDFs/opa/2015/2.10.15%20NIH%20Funding%20Cuts%202-pager.pdf. Accessed September 18, 2015.
 Ibid. Accessed August 31, 2015.
 Executive Office of the President. Statement of administration policy. H.R. 6 – 21st Century Cures Act. https://www.citizen.org/sites/default/files/saphr6r_20150708_0.pdf. Accessed September 18, 2015.