Joint replacements are the #1 expenditure of Medicare. The process of approving these medical devices is flawed according to the Institute of Medicine. It is time for patients' voices to be heard as stakeholders and for public support for increased medical device industry accountability and heightened protections for patients. Post-market registry. Product warranty. Patient/consumer stakeholder equity. Rescind industry pre-emptions/entitlements. All clinical trials must report all data.
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Tuesday, July 21, 2015

US Senate Must NOT Pass 21st Century Cures Bill


How Not to Fix the F.D.A.

By THE EDITORIAL BOARD      JULY 20, 2015
A bill passed by the House and ostensibly designed to streamline the Food and Drug Administration is loaded with bad provisions and may not even be necessary. The Senate should either eliminate or rewrite the flawed provisions before passing its version of the legislation.
The bill would weaken the F.D.A.’s already flimsy regulation of medical devices, posing a threat to future patients who have devices implanted that cannot easily be removed if found defective. It would allow a drug to be tested on humans based on only limited evidence that it is safe and effective.
It would expedite the use of new antibiotics by providing financial incentives to hospitals to use them — benefiting manufacturers but also driving up costs and encouraging overuse, potentially breeding resistant superbugs. It would extend exclusive rights for manufacturers to market high-priced, brand-name drugs if they gain a new approval to treat a rare condition. And it would open a wide loophole in rules requiring companies to report payments they make to doctors to get them to prescribe their drugs.
While the bill has some valuable provisions — like making experimental drugs available more quickly to patients who have illnesses that cannot be cured, and promoting the development of treatments based on an individual’s genetic data — those elements don’t justify the bill’s passage in its current form.
The F.D.A. was once routinely vilified for sluggishness and timidity, but with the help of industry funding it has made enormous progress in speeding up its reviews and approvals. The agency testified in April that its drug review times are consistently faster than those of all other advanced regulatory agencies around the world, with the result that American patients receive new drugs sooner than people elsewhere. In 2014, the F.D.A. approved the largest number of new drugs in almost 20 years and also reduced the review times for devices.
A big reason the bill won bipartisan support in the House is that it would increase funding for the National Institutes of Health by $8.75 billion over the next five years, ending a decade of mostly stagnant funding. And any improved Senate version should certainly include new money.
Special interest money also played a role, with many of the top supporters of the legislation having received hundreds of thousands of dollars in contributions from the pharmaceutical industry and the medical device industry last year, according to the nonpartisan Center for Responsive Politics.

The Senate will take up a similar bill later this year. When it does, it needs to cure its many flaws, while also providing sufficient funds to the F.D.A. to meet its ever-increasing workload.

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