He Regulated Medical Devices. His Wife Represented Their Makers.; The New York Times, August 20, 2024

 Christina Jewett, The New York Times; He Regulated Medical Devices. His Wife Represented Their Makers.

"For 15 years, Dr. Jeffrey E. Shuren was the federal official charged with ensuring the safety of a vast array of medical devices including artificial knees, breast implants and Covid tests.

When he announced in July that he would be retiring from the Food and Drug Administration later this year, Dr. Robert Califf, the agency’s commissioner, praised him for overseeing the approval of more novel devices last year than ever before in the nearly half-century history of the device division.

But the admiration for Dr. Shuren is far from universal. Consumer advocates see his tenure as marred by the approval of too many devices that harmed patients and by his own close ties to the $500 billion global device industry.

One connection stood out: While Dr. Shuren regulated the booming medical device industry, his wife, Allison W. Shuren, represented the interests of device makers as the co-leader of a team of lawyers at Arnold & Porter, one of Washington’s most powerful law firms."

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."

Parmesan cheese you sprinkle on your penne could be wood; Bloomberg News via Pittsburgh Post-Gazette, 2/16/16

Lydia Mulvany, Bloomberg News via Pittsburgh Post-Gazette; Parmesan cheese you sprinkle on your penne could be wood:

"Acting on a tip, agents of the U.S. Food and Drug Administration paid a surprise visit to a cheese factory in rural Pennsylvania on a cold November day in 2012.

They found what they were looking for: evidence that Castle Cheese Inc. in Slippery Rock was doctoring its 100 percent real Parmesan with cut-rate substitutes and such fillers as wood pulp and distributing it to some of the country’s biggest grocery chains...

Some grated Parmesan suppliers have been mislabeling products by filling them with too much cellulose, a common anti-clumping agent made from wood pulp, or using cheaper cheddar, instead of real Romano.

Castle president Michelle Myrter is scheduled to plead guilty this month to criminal charges. She faces up to a year in prison and a $100,000 fine.

German brewers protect their reputations with Reinheitsgebot, a series of purity laws drawn up 500 years ago. Champagne makers prohibit most vineyards outside their turf from using the name. Now the full force of the U.S. government has been brought to bear defending the authenticity of grated hard Italian cheeses."

Frances Oldham Kelsey, F.D.A. Stickler Who Saved U.S. Babies From Thalidomide, Dies at 101; New York Times, 8/7/15

Robert D. McFadden, New York Times; Frances Oldham Kelsey, F.D.A. Stickler Who Saved U.S. Babies From Thalidomide, Dies at 101:

"The sedative was Kevadon, and the application to market it in America reached the new medical officer at the Food and Drug Administration in September 1960. The drug had already been sold to pregnant women in Europe for morning sickness, and the application seemed routine, ready for the rubber stamp.

But some data on the drug’s safety troubled Dr. Frances Oldham Kelsey, a former family doctor and teacher in South Dakota who had just taken the F.D.A. job in Washington, reviewing requests to license new drugs. She asked the manufacturer, the William S. Merrell Company of Cincinnati, for more information.

Thus began a fateful test of wills. Merrell responded. Dr. Kelsey wanted more. Merrell complained to Dr. Kelsey’s bosses, calling her a petty bureaucrat. She persisted. On it went. But by late 1961, the terrible evidence was pouring in. The drug — better known by its generic name, thalidomide — was causing thousands of babies in Europe, Britain, Canada and the Middle East to be born with flipperlike arms and legs and other defects.

Dr. Kelsey, who died on Friday at the age of 101, became a 20th-century American heroine for her role in the thalidomide case, celebrated not only for her vigilance, which spared the United States from widespread birth deformities, but also for giving rise to modern laws regulating pharmaceuticals.

She was hailed by citizens’ groups and awarded honorary degrees. Congress bestowed on her a medal for service to humanity and passed legislation requiring drug makers to prove that new products were safe and effective before marketing them. President John F. Kennedy signed the landmark law that she had inspired, and presented her with the nation’s highest federal civilian service award."