Letter Urging Senators to Protect Patient Safety in Innovation Health Bill & Provide Mandatory $$$ for NIH & FDA

May 24, 2016

The Honorable #{Fname} #{Lname}

United States Senate

Washington, DC 20510

 

Dear Senator #{Lname},

A recent STAT-Harvard poll shows that a majority of Americans oppose changing federal regulations to speed the development and approval of new medical products. They are concerned that speeding approvals would lower safety and effectiveness standards for medical products.1 As members of the Patient, Consumer, and Public Health Coalition, we share those concerns.  We also write to emphasize that any effort to develop safe and effective medical products should include mandatory new funding for the National Institutes of Health (NIH) and the Food and Drug Administration (FDA).

The House’s 21st Century Cures Act and its Senate companion legislation should focus more on ensuring that medical products are safe and effective and less on speeding medical products to the market. We appreciate that the Senate bills were less dangerous for patients than the House legislation. But, we opposed 6 of the 19 bills that the Senate passed out of the HELP Committee because they were not beneficial to patients.

When these bills (which we’ve listed below) reach the Senate floor, we strongly urge you to oppose them because they weaken FDA’s safety and effectiveness standards.

 Current and former FDA Commissioners have expressed their concerns as well. Current FDA Commissioner, Robert Califf recently said, “This legislation, if not carefully crafted, could pose significant risks for FDA and American patients…Innovative therapies are not helpful to patients if they don’t work, or worse, cause harm.” 2 Former FDA Commissioner David Kessler, who in the 1990s led the FDA under presidents from both parties, said, “It’s time to uncouple the promise of research funding from the requirement that FDA standards be lowered.”3

The underlying premise of the House and Senate bills seems to be that the FDA needs to speed up its approval process. This premise is based on the erroneous claim that other countries approve medical products more quickly. Nearly two-thirds of the novel drugs approved in 2015 (29 of 45, 64%) were approved in the United States before being approved in any other country.4 In fact, a Forbes article expressed concern that the pendulum has swung too far and that “the FDA is basically providing a rubber stamp” for drug approvals and that drug approvals are at an all-time high.5 Similarly, research indicates that “it takes the same amount of time or less for patients to gain access to innovative, high-risk medical devices” in the U.S. as compared to Germany, France, Italy, and Britain.6 Approximately 99% of all regulated medical devices are cleared by the FDA through the speedy and less-than-rigorous 510(k) process, and the FDA reviews 90% of those applications within 90 days.7 With the emphasis on speed over safety it is not surprising that millions of Americans have been harmed needlessly from defective medical devices such as surgical mesh, metal-on-metal hips, power morcellators, duodenal scopes, birth control devices (Essure), and inaccurate medical device software. It is clear that we need stronger device safety regulations and better postmarket surveillance. When there are problems with medical devices in the real world, patients need to be notified as soon as possible.

Members of our coalition are particularly concerned about the following bills:

MEDTECH Act (S. 1101)

The MEDTECH Act deregulates Electronic Health Records (EHRs) and other electronic health technology. This prevents the FDA from collecting adverse event data or recalling defective software, even when the devices have life-threatening flaws.  The National Center for Health Research studied FDA-reported recalls of medical software, identifying more than 600 software devices and 1.4 million units recalled for moderate or high risk patient safety issues.  They found that if medical software is removed from FDA regulatory oversight, millions of patients would be at risk from defective software. For example, oncology electronic medical record systems were recalled in the past because they calculated and recorded incorrect drug dosages. Clinical decision support systems used during surgery were recalled because they erroneously switched patient data and failed to warn physicians about dangerous drug reactions.

Advancing Breakthrough Devices for Patients Act (S. 1077)

This bill would set a low bar for medical devices to qualify for breakthrough status, and encourage shorter or smaller clinical trials, which would make it difficult if not impossible to include subpopulations (women, seniors, racial and ethnic minorities) in the analysis of the trials. The bill would also push FDA to rely on post-market studies rather than ensuring safety or effectiveness before hospitals and patients pay for the devices. A 2015 GAO report found that most required post-market device studies are never completed. In other words, if this bill passes, there would be no conclusive evidence pre-market or post-market.

The Advancing Hope Act (S. 1878)

Priority review vouchers allow FDA priority reviews to go to the highest bidder rather than allowing the FDA to prioritize matters of the most public health importance.  The bill’s priority review vouchers would be applied to drugs that are already in development rather than spurring new drugs because of the long drug development cycle.

The Medical Countermeasure Innovation Act (S. 2055)

This bill establishes a new priority review voucher program for medical countermeasures (e.g. antidotes to anthrax and other bioweapons). As with existing priority review voucher programs, it does not necessarily reward innovation and prevents FDA from prioritizing matters of greatest public health importance.

The Combination Product Regulatory Fairness Act (S. 1767)

This bill would broaden the ability of combination products to be classified as devices.  This would inappropriately allow products that should be classified as drugs to go through the FDA’s less rigorous device clearance/approval process.

Patient Focused Impact Assessment Act (S. 1597)

The Patient Focused Impact Assessment Act adds a new layer of bureaucracy to the FDA, does not provide safeguards to ensure that patient perspectives will be free of industry influence, and may provide a mechanism for industry to promote drugs directly to consumers for off-label uses.

REGROW Act (S. 2689)

The REGROW Act is the latest effort to lower research standards and deregulate new treatments. Although this bill was not part of the HELP Committee markups held earlier this year, we understand it might be added to a package bill. The Act allows complex biologic therapies to be conditionally approved without phase III trials and prescribed to patients based on studies in a limited population without proof that the new therapy actually works. If this Act passes, it could lead to the Centers for Medicare and Medicaid (CMS) wasting billions of dollars on medications that were approved by the FDA but do not work.

The Alliance for Regenerative Medicine (ARM) does not support the REGROW Act, because those researchers want  “to ensure access to safe and effective regenerative medicine therapies without putting patients at risk, disadvantaging American therapeutic developers and potentially damaging a very promising field of medicine”(emphasis added).[7]  In her recent article about stem cell research in the New England Journal of Medicine, University of Wisconsin law professor and biomedical ethicist R. Alta Charo said, “The best way to find safe effective cures is through the careful steps of clinical trials and treatment monitoring.”8

 For the remaining Senate FDA-NIH bills, we urge you to only support them if they provide mandatory new funding for the National Institutes of Health (NIH) and the Food and Drug Administration (FDA).   If mandatory funding is not included, we strongly urge you to vote against the bills.

 Funding for NIH & FDA

Prior to last year’s $2 billion one-time funding increase, NIH’s funding remained flat for more than a decade (about $30 billion per year).9 Unfortunately, the Cures Act $9 billion increase in NIH research funding is still below what it would have been had Congress not previously allowed NIH’s annual budget to stagnate.10

The Cures Act also would provide the FDA with $550 million in new mandatory funding over five years, but the amount of money pales to the additional workload that the Act assigns to the FDA. New FDA Commissioner, Robert Califf, has warned that Congress needs to provide the FDA with an “adequate and stable source of funding” for the mandates in the legislation.11

Adequately funding NIH is essential if we are serious about the Vice President’s Cancer Moonshot, precision medicine, and efforts to find treatments for Alzheimer’s disease, autism, depression, schizophrenia, addiction and other maladies.12  Underfunding the FDA is likely to slow the approval of new medical products because the agency’s workload has been significantly increased with unfunded mandates.

Conclusions

Members of our coalition agree with most Americans in opposing regulations that would speed the approval of medical products by lowering FDA’s safety and effectiveness standards. We strongly urge you to oppose any bill that weakens FDA’s safety and effectiveness standards, and to ensure that any legislation aimed at improving medical treatments include new mandatory funding for the NIH and the FDA. 

AMWA

Breast Cancer Action

Center for Medical Consumers

Connecticut Center for Patient Safety

MAME

MedShadow Foundation

MISSD

MRSA Survivors Network

National Center for Health Research

National Consumers League

National Organization for Women

National Physicians Alliance

National Women’s Health Network

Quinolone Vigilance Foundation

The TMJ Association

Washington Advocates for Patient Safety

WoodyMatters

  1. Nather D, Kaplan S (May 11, 2016). Public wary of faster approvals of new drugs, STAT-Harvard poll finds, STAT. href=”https://www.statnews.com/2016/05/11/stat-harvard-poll-drug-approvals/”>https://www.statnews.com/2016/05/11/stat-harvard-poll-drug-approvals/  
  2. Burton TM (May 12, 2016). Experts Decry Tying Medical Research Funds to FDA Standards Changes, The Wall Street Journal. http://goo.gl/m5gyGT  
  3. Burton TM (May 12, 2016). Experts Decry Tying Medical Research Funds to FDA Standards Changes, The Wall Street Journal. http://goo.gl/m5gyGT  
  4. Herper M (August 20, 2015). VIEWS: The FDA Is Basically Approving Everything. Here’s The Data To Prove It. href=”http://www.forbes.com/sites/matthewherper/2015/08/20/the-fda-is-basically-approving-everything-heres-the-data-to-prove-it/#23cbf9934938″>http://www.forbes.com/sites/matthewherper/2015/08/20/the-fda-is-basically-approving-everything-heres-the-data-to-prove-it/#23cbf9934938  
  5. Herper M (August 20, 2015). VIEWS: The FDA Is Basically Approving Everything. Here’s The Data To Prove It. href=”http://www.forbes.com/sites/matthewherper/2015/08/20/the-fda-is-basically-approving-everything-heres-the-data-to-prove-it/#23cbf9934938″>http://www.forbes.com/sites/matthewherper/2015/08/20/the-fda-is-basically-approving-everything-heres-the-data-to-prove-it/#23cbf9934938  
  6. Baus S, Hassenplug JC (August 9, 2012). Patient Access to Medical Devices—A comparison of U.S. and European Review Processes. New England Journal of Medicine. href=”http://www.nejm.org/doi/full/10.1056/NEJMp1204170?rss=searchAndBrowse”>http://www.nejm.org/doi/full/10.1056/NEJMp1204170rss=searchAndBrowse  
  7. Food and Drug Administration (2011). Analysis of Premarket Review Times Under the 510(k) Program. http://goo.gl/3JlkzQ  
  8. Char, RA (March 10, 2016). On the Road (to a Cure?)—Stem-Cell Tourism and Lessons for Gene Editing, Perspective, New England Journal of Medicine. http://goo.gl/jhfsCC  
  9. MacGillis A (October 20, 2015). Would Washington’s FDA Fix Cure the Patients or the Drug Industry? ProPublica . href=”https://www.propublica.org/article/would-washingtons-fda-fix-cure-the-patients-or-the-drug-industry”>https://www.propublica.org/article/would-washingtons-fda-fix-cure-the-patients-or-the-drug-industry  
  10. National Institutes of Health (Accessed May 13, 2016). National Institutes of Health History of Congressional Appropriations, Fiscal Years 2000 2016. href=”https://goo.gl/jjwExj”>ttps://goo.gl/jjwExjf  
  11. Mixter B (May 6, 2016). FDA Head Cites Concerns with Cures Bill, Bloomberg href=”http://www.bna.com/fda-head-cites-b57982070805/”>http://www.bna.com/fda-head-cites-b57982070805/  
  12. Health and Human Services (Accessed May 13, 2016). President’s HHS FY 2017 Budget http://www.hhs.gov/about/budget/fy2017/budget-factsheet/index.html />factsheet/index.html#