FTC Challenenges ‘junk’ patents held by 10 drugmakers, including for Novo Nordisk’s Ozempic; CNBC, April 30, 2024

 Annika Kim Constantino, CNBC; FTC Challenenges ‘junk’ patents held by 10 drugmakers, including for Novo Nordisk’s Ozempic

"Most top-selling medications are protected by dozens of patents covering various ingredients, manufacturing processes, and intellectual property. Generic drugmakers can only launch cheaper versions of a branded drug if the patents have expired or are successfully challenged in court.

“By filing bogus patent listings, pharma companies block competition and inflate the cost of prescription drugs, forcing Americans to pay sky-high prices for medicines they rely on,” FTC Chair Lina Khan said in a release. “By challenging junk patent filings, the FTC is fighting these illegal tactics and making sure that Americans can get timely access to innovative and affordable versions of the medicines they need.”

The FTC also notified the Food and Drug Administration about the challenges. The FDA manages patent listings for approved drugs on a document called the Orange Book.

The FTC first challenged dozens of branded drug patents last fall, leading three drugmakers to comply and delist their patents with the FDA. Five other companies did not. 

The Tuesday announcement expands the Biden administration’s effort to crack down on alleged patent abuses by the pharmaceutical industry. The FTC has argued that drugmakers are needlessly listing dozens of extra patents for branded medications to keep their drug prices high and stall generic competitors from entering the U.S. market."

Counterfeit Covid Masks Are Still Sold Everywhere, Despite Misleading Claims; The New York Times, November 30, 2021

 Andrew Jacobs, The New York Times; Counterfeit Covid Masks Are Still Sold Everywhere, Despite Misleading Claims

"“It’s really the Wild West out there with so many bad actors ripping people off,” said Anne Miller, executive director of Project N95, a nonprofit that connects people to bona fide personal protective equipment."

Drug Company ‘Shenanigans’ to Block Generics Come Under Federal Scrutiny; The New York Times, April 14, 2018

Robert Pear, The New York Times; Drug Company ‘Shenanigans’ to Block Generics Come Under Federal Scrutiny

"At a time when researchers are using sophisticated science to develop new treatments and cures, the fight over physical samples — a few thousand pills — sounds mundane. But it has huge implications for consumers’ access to affordable medicines.

The F.D.A. says it has received more than 150 inquiries from generic drug companies unable to obtain the samples needed to show that a generic product works the same as a brand-name medicine. Some of the disputes over samples involve drugs that are costly to patients and to the Medicare program and that have experienced sharp price increases in recent years.

“Without generic competition, there is no pressure to drive down the costs of these medications,” the food and drug agency said. Under current law, it said, it cannot compel a brand-name drug manufacturer to sell samples to a generic company."

Why the FDA hides the names of grocery stores that sell contaminated food; Washington Post, March 13, 2017

Caitlin Dewey, Washington Post; Why the FDA hides the names of grocery stores that sell contaminated food

"The SoyNut Butter and a related granola were sold in stores across the country, according to the Food and Drug Administration. It was also served in an untold number of child-care centers and schools.

The FDA does not specify, however, which stores, centers or schools — because that would violate its interpretation of an obscure trade secret rule...

In the case of releasing retailer lists during major outbreaks, the FDA has historically sided with business, ruling that such lists constitute “confidential commercial information” and thus should not be available for public consumption."