WASHINGTON, Nov. 22, 2016 /PRNewswire/ -- Experts from opposite ends of the ideological spectrum were united over concern about the 21st Century Cures Act at an emergency briefing in the U.S. Senate yesterday. While highlighting different problems, they agreed that Congress should not rush a closed-door negotiated version of the bill during the lame-duck session.
We are in the midst of nationwide concern and discussion about healthcare issues and how best to handle them. "We each recognize there are deep problems within the FDA that have resulted in dangerous drugs and medical devices on the market," said panelist Jonathan Emord, Esq. A majority of Americans do not think the FDA is doing a good job of regulating safety and effectiveness, according to a poll examining public opinion on the 21st Century Cures Act and the similar Senate package, conducted by Stat and Harvard TH Chan School of Public Health.
The FDA has a medical device approval pathway referred to as 510(k), which allows for device approval without standard clinical trials. Under FDA practices, the vast majority of medical devices are now approved under the 510(k) process within 90 days, according to panelist Dr. Diana Zuckerman, president of National Center for Health Research. She added, "Over a 1-year period, almost half a billion 510(k) approved devices were recalled as high-risk, some having caused death."
The majority of Americans oppose measures included in the 21st Century Cures Act, that change standards in order to speed the approval of new drugs and devices, according to the Stat and Harvard poll.
The panel had experts from the conservative Heritage Foundation to the progressive National Center for Health Research. "Concern about the lame duck session push and the dangerous consequences of this legislation brought this diverse panel together," said panelist Jonathan Emord, Esq.
Mr. Emord noted the already large number of drug and device recalls as a result of damages suffered by individuals in the public. He said, "Though the FDA's medical scientists may recommend rejecting a product, too often political managers, beholden to industry, override them and grant approval." He further stated, "This bill comes at a time when the FDA is broken. Without rectifying this, the bill gives more power and discretion to the agency managers responsible for the dangerous products."
Justin Bogie, Senior Policy Analyst in Fiscal Affairs at Heritage Foundation, focused on the issue of mandatory funding in the bill, saying this tends to put programs on autopilot and then they are not adequately reviewed to see if they are beneficial. He said, "Congress should reject the 21st Century Cures Act in its current form . . . This bill would set a bad precedent that could have negative impact on other legislation, and the budget as a whole, in the future."
Dr. Zuckerman provided data on the large number of drugs that showed promise in early stages of review, only to be proven ineffective or worse in later stages. This datum is key to concerns about a provision in the bill that allows for approval based on early stage indicators.
The Veterans Health Administration is America's largest health care system, serving 8.76 million veterans annually. Representing veterans concerns, panelist Major Eric Montalvo, US Marine Corps (Ret.) said, "As a result of provisions in the bill that reduce testing requirements and expedite processes, the bill will place veterans at greater risk of adverse consequences." He expressed concern about ECT (electroconvulsive therapy), a device which has not gone through standard clinical trials, and the American Psychiatric Association's recent promotion of it for veterans with Post-Traumatic Stress. Major Montalvo wants greater accountability for damage done to veterans.
Panelists commented on the lack of transparency regarding the current version of 21st Century Cures Act and the Senate package that have been negotiated by leadership behind closed doors, bypassing committee hearings and opportunities for amendments. There was consensus that there will not be adequate time to review or amend this unseen version and it should not be rushed to a vote during the lame duck session.
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SOURCE Emord & Associates, P.C.