About COVID-19
U.S. CDC chief says there will be no federal mandate on COVID-19 vaccine: “U.S. Centers for Disease Control and Prevention Director Dr. Rochelle Walensky said on Friday there will be no nationwide mandate for Americans to get a COVID-19 vaccine, clarifying comments she made earlier during a televised interview.”
FDA vows ‘all hands on deck’ effort to get Pfizer coronavirus vaccine full approval as quickly as possible: “With coronavirus cases surging, the Food and Drug Administration’s top vaccine official said Friday the agency is redeploying staff and adding computer and other technical resources to accelerate an effort to grant the Pfizer coronavirus vaccine full approval as rapidly as possible.
‘We have rolled out an all hands on deck’ strategy to identify ways to expedite approval of the vaccine, which is currently being administered under the FDA’s emergency use authority, said Peter Marks, director of the Center for Biologics Evaluation and Research, in an interview.”
About pharma
FTC drops antitrust case against AbbVie, but still decries the company's 'ill-gotten gains': “Appealing a $448 million judgement in an antitrust case has ultimately paid off for AbbVie.
On Friday, the U.S. Federal Trade Commission withdrew its complaint that AbbVie (then under the umbrella of Abbott Laboratories) used sham litigation in 2011 to illegally block generic competition for its testosterone drug AndroGel. While the agency still thinks AbbVie engaged in ‘anticompetitive conduct,’ an official said current laws don't support the agency's efforts to recoup money for consumers.”
The Top 10 Most Expensive Popular Generic Drugs in the US (and How to Save): From Good Rx. Two of the top 10 are erectile dysfunction drugs.
FDA allows drugs without proven clinical benefit to languish for years on accelerated pathway: “Since the US Food and Drug Administration established its accelerated approval pathway for drugs in 1992, nearly half (112) of the 253 drugs authorised have not been confirmed as clinically effective, an investigation by The BMJ has found.
Of these 112 drugs approved in the past 28 years, a fifth (24) have been on the market for more than five years and some for more than two decades—often with a hefty price tag, shows an in-depth analysis of FDA data to 31 December 2020, conducted by The BMJ.
The accelerated pathway allows drugs onto the market before efficacy has been proved. As part of this approval, however, the manufacturer must conduct post-approval studies—known as phase IV confirmatory trials—to ‘verify the anticipated clinical benefit.’ If these trials show no benefit the drug’s approval can be cancelled.
Further analysis of FDA data shows that only 16 drugs approved through the pathway have ever been withdrawn. Most of these were shown to lack efficacy, but in some cases the confirmatory trials were never done. Celecoxib (Celebrex), which was given accelerated approval in 1999 for the treatment of familial adenomatous polyposis, was on the market for 12 years before the FDA finally asked Pfizer to voluntarily withdraw it for this indication because the efficacy trials were never done.”
About health insurance
DOJ joins false claims suit against Kaiser Permanente: “According to the lawsuits, Kaiser Permanente pressured its physicians to include addenda on patient records to additional diagnoses. These updates were at times made months or more than a year later, for conditions the patient did not have or that were not considered at the time of their visit, the DOJ said.
The false claims allegations were initially filed in a series of whistleblower suits, the DOJ said.”
NPs get prison time for telemedicine fraud: “Two nurse practitioners have been sentenced to prison and ordered to pay restitution for conspiring to defraud Medicare, the U.S. Justice Department announced July 30.
Janae Harper, NP, 34, of Kalispell, Mont., was sentenced to 12 months in prison and ordered to pay $4.3 million in restitution. Mark Hill, NP, 54, of Edinburg, N.D., received a nine-month prison sentence and was ordered to pay $5.1 million in restitution. The sentences were handed down after both defendants pleaded guilty to conspiracy to commit healthcare fraud.
The government alleged Ms. Harper worked with staffing and telemedicine companies to commit healthcare fraud from late 2017 through July 2019. She allegedly received money to sign brace orders that were prepared by telemarketers who had no medical training. She allegedly signed 7,673 brace orders, which resulted in $8.3 million billed to Medicare, according to the Justice Department.
The government alleged Mr. Hill also worked with telemedicine and staffing companies to commit fraud. He was allegedly paid to sign brace orders for Medicare beneficiaries from October 2017 through April 2019. He allegedly signed 7,097 brace orders, which resulted in $10.1 million billed to Medicare.”