Passage of H.R. the Food and Drug Amendments of 2022

Floor Speech

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Ms. JAYAPAL. Madam Speaker, I rise today on the passage of H.R. 7667 the ``Food and Drug Amendments of 2022.'' Though I am grateful for many of the provisions in this bipartisan legislation, I have strong concerns that this bill does not go far enough to protect the American people--both patients and their doctors. This reauthorization, only occurring every five years, is one of our greatest opportunities to hold the pharmaceutical industry accountable and to the highest standards possible to ensure access and protection for patients across the country.

Typically, this routine reauthorization of user fees is coupled with incentives directed toward the pharmaceutical and medical device industry. With each reauthorization to date, we have seen the increased adoption of expedited review pathways leaving patients and their doctors more uncertain that FDA approved treatments are truly effective or safe. Often, these new pathways that hasten FDA's regulatory review are coupled with financial incentives including exclusivity periods that prolong high monopoly prices such that the American public is paying more for less. Last year's controversial approval of the Alzheimer's disease drug, aducanumab (Aduhelm) laid bare this reality when the FDA approved this drug under the accelerated approval pathway despite harms including brain bleeding and swelling as well as uncertain clinical benefit. This shifted the focus of this year's user fee reauthorization efforts away from shortening FDA review times for new health technologies to reforms to reinstate public trust into FDA 's approval process.

FDA's accelerated approval pathway can be an important way for promising drugs to reach patients. But pharmaceutical corporations have largely failed to uphold their end of the bargain of completing critical studies to confirm that these drugs are truly beneficial. Instead, accelerated approval is being used by Big Pharma to drive further profits at the expense of patient safety and Medicare spending. Although H.R. 7667 would allow for greater FDA oversight of the accelerated approval pathway, this bill should have included much stronger reforms for accelerated-approval drugs.

This bill should have made sure that FDA publicly engages with their advisory committees instead of industry sponsors behind closed doors. Recent studies have found that FDA has convened these independent experts less frequently--between 2010 and 2021, FDA went from hearing these groups for 55 percent of approved drugs to just 6 percent. Transparency is paramount to ensuring trust in our government institutions. We should codify that meetings are made public and nothing should obscure a patient's ability to see how and why a therapeutic approval was granted.

Moreover, the bill should ensure that lower standards of evidence cannot be accepted to approve a drug. Clarification is needed to ensure that Real World Evidence (RWE) is appropriately used to augment the post-approval studies that prove therapies approved are truly effective and research has shown that RWE has demonstrated promise for complementing clinical trials but not replacing them. When it comes to the safety of our constituents, we must ensure that speedy access does not eclipse safety.

A recent study published in JAMA Health Forum explored how much Medicare and Medicaid spend on drugs granted accelerated approval by the FDA both before and after the drug's clinical benefit is confirmed. The study found that for the 38 drugs granted accelerated approval by the FDA between 2012 and 2017:

CMS spent almost $70 billion through 2020 on these drugs;

just over $50 billion (75 percent) was spent after the accelerated approval drugs were converted to standard approval following completion of their required confirmatory trials; but

almost 60 percent ($40 billion) of this spending was for drugs with confirmatory trials evaluating surrogate endpoints instead of assessing meaningful clinical endpoints demonstrating the effect of these drugs on how patients feel, function, or survive.

In addition, this bill should squarely place patient safety at its core and mandate the automatic withdrawal of drugs, preliminarily approved under accelerated approval, that fail to prove efficacy. Not explicitly mandating that approval should expire one year after any target date of study completion, and in no case later than five years after the product is approved unless certain criteria relative to post approval studies are achieved, is a significant concession to the pharmaceutical industry that puts patients and payers at risk of prolonged medical and financial harms. There should be no barriers to removing a drug that at best is ineffective and at worst dangerous.

Another troubling inclusion in the approved measure are additional provisions that would empower a sponsor company to request a meeting with the FDA Commissioner, a public comment period followed by responses by the agency, and a convening of the advisory committee to review the agency's request for withdrawal, wasting precious time. Rather, the Secretary should have the power to convene and consult an advisory committee if the review is needed, not if it is mandated by the sponsor company. Given current FDA resources and staffing constraints, providing due notice with an explanation for the proposed withdrawal is sufficient. There should be no delay in protecting the health and safety of patients.

We must ensure that the expedited therapeutic review process is transparent and fair--not a revolving door between the agency and industry. As of 2020, we have spent over $40 billion in taxpayer dollars for drugs that never demonstrated benefit, all to line the pockets of pharmaceutical corporations. This is another example of why further reforms are needed to ensure we are protecting our constituents across the country and being thoughtful arbiters of this reauthorization, which will define patient access and safety for the next five years.

I am glad to see the bipartisan efforts achieved in the passage of H.R. 7667, but I do not believe this should be the last word on accelerated approval. I want to officially submit my concern that this bill does not go far enough to protect patients from unnecessary risk of exposure to unproven, ineffective, and potentially dangerous therapies. I hope to continue working with my colleagues to ensure the correct balance is struck between timely and safe access to therapies needed in the final passage of a bi-cameral reauthorization.

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