[Congressional Record Volume 168, Number 102 (Wednesday, June 15, 2022)]
[Extensions of Remarks]
[Pages E629-E630]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




       PASSAGE OF H.R. 7667, THE FOOD AND DRUG AMENDMENTS OF 2022

                                 ______
                                 

                          HON. PRAMILA JAYAPAL

                             of washington

                    in the house of representatives

                        Wednesday, June 15, 2022

  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

[[Page E630]]

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.

                          ____________________