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| REUTERS/Kent Nishimura |
The Food and Drug Administration aims to let only safe and effective drugs reach the US market — but its turtle-speed approval process may be killing more patients than it protects.
FDA regulations have made long delays in clearing medical products the agency’s norm.
As far back as 1980, the great economist Milton Friedman was pointing to the FDA as Exhibit A in America’s over-regulation problem.
It can take a decade or more to clear new medicines through the FDA’s regulatory labyrinth, which requires companies to prove two things: that a drug is safe for patient use, and that it is an effective treatment for a particular ailment.
The latter is the stumbling block.
Most of America’s health-care spending — the 85% of it spent on medical procedures or other care, not pharmaceuticals — involves no bureaucratic “help” to determine efficaciousness.
Moreover, once the FDA approves a drug for one disease, doctors routinely prescribe it “off label,” without any government involvement, often finding that it’s effective for other ailments as well.
So why can’t the private sector do the same in the first place, once a drug has passed FDA-regulated safety trials?
Why must American patients wait years, suffering with and even dying of potentially curable illnesses, while bureaucrats put treatments through the evidentiary wringer?
It costs $2 billion or more to bring each successful drug to market, given that about 90% of them must be abandoned during the lengthy FDA process.
The government’s byzantine and unpredictable approval procedures thus divert billions of dollars of vital and scarce investment capital away from drugs that could cure cancer, heart disease, emphysema and other killer ailments.
The two of us sometimes consult with drug companies to help them navigate the FDA maze — and we’ve seen many promising drugs bottled up by the bureaucracy.
One of them shows great potential in slowing the memory-loss progression of early-stage Alzheimer’s. There’s currently no similar treatment, but the FDA wants to hold it back for many more years of effectiveness trials.
The FDA is currently considering a drug for ataxia, a rare neurological disease that often has agonizing effects. The drug has been studied for more than eight years and is totally safe.
But anecdotal evidence of its effectiveness from leading ataxia experts is not enough: The FDA is demanding lengthy and expensive additional studies to prove it.
Why deny a ray of hope to suffering patients? --->READ MORE HERE
A Morgantown man has pleaded guilty before U.S. Magistrate Judge Michael John Aloi to wire fraud and failure to withhold or pay over tax in an alleged COVID-19 relief scheme.
James Baldwin II, originally from Buckhannon, stipulated to owing the U.S. Small Business Administration $748,230, and to owing the IRS $258,993.
Final plea acceptance, and sentencing, will fall with Article III Judge Thomas S. Kleeh, the Northern District’s chief U.S. district judge.
The charges stem from a scheme to defraud the United States by submitting fraudulent applications for the Paycheck Protection Program (PPP). The PPP, created under the Coronavirus Aid, Relief, and Economic Security (CARES) Act, was designed to provide financial assistance to businesses impacted by the COVID-19 pandemic. The scheme allegedly occurred between on or about July 1, 2020, and continuing until in or about Nov. 18, 2021.
Baldwin allegedly submitted fraudulent PPP applications for multiple businesses, including JB Decks, WV Decks, Morgantown Decks, and SelectDecks, LLC, by making false statements about the businesses, their number of employees, and gross income.
For JB Decks, Baldwin applied for loans totaling $264,120.00 after allegedly falsely reporting the company was established in July 2008, employed nine individuals, and had an average monthly payroll of $52,824. Supporting documents were allegedly falsified, including an SS-4 that he reported the IRS assigned on July 28, 2008, when it was actually issued on July 28, 2020. A Business Registration Certificate from the West Virginia Secretary of State was dated July 29, 2008, when it was actually issued on July 28, 2020.
Baldwin was approved for a $132,060.00 first draw PPP loan on Aug. 3, 2020, and a $132,060 second draw loan on March 2, 2021, for JB Decks.
The wire fraud charge is based on an Aug. 3, 2020, internet transmission, “originating from the Northern District of West Virginia to the SBA server in Virginia,” which constituted a false and fraudulent PPP loan application for JB Decks. --->READ MORE HEREFollow links below to relevant/related stories and resources:
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