September 18, 2014
The Honorable Henry Waxman
Energy and Commerce Committee
United States House of Representatives
Washington, DC 20515
Dear Ranking Member Waxman,
As members of the Patient, Consumer, and Public Health Coalition, which includes organizations representing patients, consumers, physicians, and scientists, we are writing to express our strong concerns about proposed legislation to speed the development of new antibiotic drugs, H.R. 3742, the Antibiotic Development to Advance Patient Treatment (ADAPT) Act of 2013.
Antibiotic resistance is of grave concern, but this legislation will create more problems than it will solve. Although the ADAPT Act would do nothing to address the root causes of antibiotic resistance (it is intended to promote antibiotic drug development), the unintended consequences would be to harm patients and threaten the public health. If passed, patients will be paying to take drugs that are not proven to improve patient health or save patients’ lives.
Below are our specific concerns:
Lowers standards of safety and efficacy
The ADAPT Act allows for approval of new antimicrobial drugs based on “alternative endpoints.” This provision of the Act could easily be abused if “alternative endpoints” were construed to include laboratory test results or mathematical modeling. These types of data would provide no proof that the drug will help patients get better and instead could result in new, more expensive drugs that do not work and harm patients more than they help them.
Although the Rule of Construction in the ADAPT Act states that nothing in the subsection entitled “Approval of Certain Drugs for Use in Limited Populations of Patients” will be construed as to alter the standards of evidence for approval of new drugs, including the “substantial evidence” standard, the “alternative endpoint” language in the Act would nevertheless likely be misused to pressure the FDA to lower approval standards regarding evidence used to approve new antibiotics.
Look at the track record for antibiotics: More than half of all antibiotics approved by the Food and Drug Administration (FDA) from 1980 to 2000 had to be removed from the market because of their risks.[i] Drugs that do not work also pose a threat to the stated intent of this legislation, because ineffective antibiotics contribute to antibiotic resistance.
Reduces diversity in clinical trials and encroaches on FDA scientific decision making
The bill states that approvals can be made based on “datasets of limited size; pharmacologic or pathophysiologic data; data from phase 2 clinical studies.” This statement specifically allows for smaller, less diverse patient populations. Studies must include at least several hundred patients in order to provide data on the safety and effectiveness for women, people over 60, children, and people of color. Legislation that encourages smaller studies would jeopardize current efforts at federal agencies such as the Food and Drug Administration and the National Institutes of Health (NIH) to ensure that clinical trials have sufficient inclusion of women, children, elderly, and racial and ethnic groups to ensure equality in clinical research.
Moreover, legislation that directly stipulates what types of evidence are acceptable to the FDA for approval decisions also raises concern over inappropriate involvement of Congress in highly technical matters that are the domain of the FDA. Most members of Congress and most Congressional staff lack scientific expertise and should not be telling FDA scientists what types of scientific evidence to consider.
Denies safeguards to protect larger patient populations
While this bill focuses on antibiotics for defined patient groups, there are no provisions to prevent these drugs from being used in the more general population in which they have not been tested for safety and efficacy. FDA approval is based on a determination of whether the benefits outweigh the risks: antibiotics with greater risks might be considered suitable for a relatively small number of patients for whom other treatments have failed, but would be unnecessarily dangerous for most patients. The bill specifically states that nothing in the bill “shall be construed to restrict, in any manner, the prescribing of antibiotics or other products by health care professionals, or to limit the practice of
health care.” In other words, the proposed bill makes clear that antibiotics approved under the ADAPT Act will be freely available for use in all patients, not a narrowly defined, very vulnerable small group, as purported by the bill’s proponents.
Instead, if this proposed bill were truly intended to speed approval of drugs targeted to patients who need a new drug because of MRSA or other resistant microbials, that limited approval should be clearly indicated by a prominent logo on the product — in addition to text in the drug label as would be required under the proposed bill — to alert clinicians and patients that the drug has only been approved for a very limited patient population and has not been shown to be safe and effective for other patients, and to discourage use in patients for whom safer, clearly effective alternative treatments are available. Use in broader populations endangers millions of Americans, and also defeats the stated purpose of this legislation.
Lacks provisions to protect and preserve new and existing antibiotics
Failing to safeguard the use of new antibiotics and ensure their judicious use will only hasten the spread of antibiotic resistance. The ADAPT Act contains only one sentence which even mentions “ensuring appropriate stewardship,” and provides no specific strategies for doing so. This omission ignores the recommendation of the Centers for Disease Control and Prevention (CDC), which stated that “Perhaps the single most important action needed to greatly slow down the development and spread of antibiotic resistant infections is to change the way antibiotics are used.”[ii] The CDC points out that currently “as much as 50% of the time, antibiotics are prescribed when they are not needed or they are misused.” By failing to provide safeguards and specifying in the proposed legislation that it has no intent “to restrict, in any manner” the prescribing of the antibiotics approved under the weaker standards the bill would encourage, this legislation would worsen the existing situation.
Ignores known causes of antibiotic resistance
The CDC 2013 report criticizes current practices regarding antibiotic use in animals as a major cause of antibiotic resistance in humans. It stated that “drug-resistant bacteria can remain on meat from animals” and if the food is “not cooked properly, the bacteria can spread to humans.”2 In 2011, 80% of antibiotics in the U.S. were used “for meat and poultry production.”[iii] The FDA has issued a voluntary guidance on the use of antibiotics for animal, which has been sharply criticized as being ineffective, and has been accompanied by actions to weaken the standards of veterinary practice in food production. The ADAPT Act is silent on this critical source of antibiotic resistance.
The CDC also recommends preventing infections by focusing on immunizations and strategies as simple as hand washing. The CDC also advises tracking the causes of infections and the risk factors that led to resistant infections. The ADAPT Act completely ignores all those CDC recommendations.
Adds unneeded redundancy to existing legislation and regulations
The ADAPT Act is built on the assumption that faster approvals will incentivize companies to develop new antibiotics. Yet the GAIN Act of 2012 already provides strong incentives to antibiotic drug makers, and according to its author, Representative Phil Gingrey, GAIN’s incentives are working. He stated in a July 2013 press release that “12 new antibiotics are currently in the final stages of approval process.” A recent Wall Street Journal article noted that more companies are working to develop new antibiotics.[iv] There is no evidence that more incentives are needed now – so why gamble by passing the ADAPT Act, which could worsen, not improve, antibiotic resistance?
In addition, the FDA already has several programs that speed drug approvals for antibiotics and other drugs. These programs include breakthrough therapy designation, fast track approval, accelerated approval, and orphan drug status.
Given the many fundamental flaws and dangerous shortcomings of this bill, we urge you to substantially revise this legislation. We look forward to working with you to create legislation that can provide real and effective solutions to the problem of antibiotic resistance. Such alternative legislation should directly confront the real causes of antibiotic resistance, rather than advocating shortcuts that compromise patient safety, exclude neglected patient populations, accelerate antibiotic resistance, and undercut the recommendations and priorities of the FDA, the CDC, and the NIH.
In its current version, the only taxpayers who are likely to benefit from the ADAPT Act are the stockholders of pharmaceutical companies. With your help, however, the legislation can be greatly improved to achieve its intended purpose: saving the lives of patients. We would welcome the opportunity to help to make that happen.
American Medical Student Association
Annie Appleseed Project
Breast Cancer Action
Center for Medical Consumers
Connecticut Center for Patient Safety
Jacobs Institute of Women’s Health
National Center for Health Research
National Women’s Health Network
The Patient, Consumer and Public Health Coalition can be reached through Paul Brown at (202) 223-4000 or at email@example.com
[i] Kesselheim, AS, Outterson K (2011). Improving Antibiotic Markets for Long Term Sustainability. Yale Journal of Health Policy, Law, and Ethics, Volume 11. Accessed February 5, 2014. http://www.ncbi.nlm.nih.gov/pubmed/21381513.
[ii] U.S. Department of Health and Human Services Centers for Disease Control and Prevention. Antibiotic Resistance Threats in the United States, 2013. Accessed February 5, 2014. http://www.cdc.gov/drugresistance/threat-report-2013/.
[iii] Plumer B, (December 14, 2013). The FDA is cracking down on antibiotics on farms. Here’s what you should know. The Washington Post. Accessed February 5, 2014. http://www.washingtonpost.com/blogs/wonkblog/wp/2013/12/14/the-fda-is-cracking-down-on-antibiotics-at-farms-heres-what-you-should-know/.
[iv] Drug Makers Tiptoe Back Into Antibiotic R&D. The Wall Street Journal (January 2014).