Government Shutdown Curtails F.D.A. Food Inspections

While the Agriculture Department continues to inspect domestic meat and poultry, the F.D.A. has reduced inspections of fruits, vegetables and other foods.

www.nytimes.com

The Food and Drug Administration has stopped routine food safety inspections of seafood, fruits, vegetables and many other foods at high risk of contamination because of the federal government’s shutdown, Dr. Scott Gottlieb, the agency’s commissioner, said on Wednesday.

F.D.A. inspectors normally examine operations at about 160 domestic manufacturing and food processing plants each week. 

Domestic meat and poultry are still being inspected by staff at the Agriculture Department, but they are going without pay. The F.D.A. oversees about 80 percent of the nation’s food supply, as well as most overseas imports.

“The announcement that they are going to try to start up high-risk inspections is a positive step. But, we’ve had outbreaks from foods that are not high risk — from flour, from packaged foods. So I think that the fact that two-thirds of establishments are not going to be inspected is still a problem.”, Sarah Sorscher, deputy director of regulatory affairs at the Center for Science in the Public Interest, an advocacy group. 

“We have a deep concern about those employees who were furloughed, their inability to fulfill their public health functions, and the tremendous personal impact that it has on them,” said Ladd Wiley, executive director of the Alliance for a Stronger F.D.A., a nonprofit advocacy group. 

“We are also grateful to the roughly 10,000 employees who are retained and working.”

• “This was the first time life expectancy in the U.S. has declined two years in a row since declines in 1962 and 1963,” the NCHS 
• The NCHS found that 63,600 people died of drug overdoses in 2016, and “the majority of these overdose deaths were unintentional,” the NCHS team, led by Dr. Holly Hedegaard, wrote.
• The death rate from drug overdoses rose 18 percent a year from 2014 to 2016, the team reported. In 1999, 6.1 per 100,000 people died from drug overdoses. That rate rose to 19.8 per 100,000 in 2016.
• Male life expectancy fell from 76.3 years in 2015 to 76.1 in 2016, while female life expectancy stayed steady at 81.1
• The Organization for Economic Cooperation and Development keeps an index of life expectancy, and the U.S. falls in between Chile and Turkey in terms of average rates, and far behind Britain, France and Greece.

FDA slams EpiPen maker for doing nothing while hundreds failed, people died

In damning letter, agency says maker didn’t fix violations or recall bad batches.

arstechnica.com|Katie Thomas

The manufacturer of EpiPen devices failed to address known malfunctions in its epinephrine auto-injectors even as hundreds of customer complaints rolled in and failures were linked to deaths, according to the Food and Drug Administration.

The damning allegations came to light today when the FDA posted a warning letter it sent September 5 to the manufacturer, Meridian Medical Technologies, Inc. The company (which is owned by Pfizer) produces EpiPens for Mylan, which owns the devices and is notorious for dramatically raising prices by more than 400 percent in recent years. 

“Nonetheless, on June 3, 2016, you concluded that the defect was infrequent, even though you had not examined all of your reserve samples to determine the extent of the defect within the same lot of finished products, nor did you expand your investigation to other lots... 

You closed your investigation and determined that “no market action would be taken.”

The Myth of Drug Expiration Dates

Hospitals and pharmacies are required to toss expired drugs, no matter how expensive or vital. Meanwhile the FDA has long known that many remain safe and potent for years longer.

www.propublica.org|Marshall Allen

In his lab, Gerona ran tests on the decades-old drugs, including some now defunct brands such as the diet pills Obocell (once pitched to doctors with a portly figurine called “Mr. Obocell”) and Bamadex. Overall, the bottles contained 14 different compounds, including antihistamines, pain relievers and stimulants. All the drugs tested were in their original sealed containers.

The findings surprised both researchers: A dozen of the 14 compounds were still as potent as they were when they were manufactured, some at almost 100 percent of their labeled concentrations.

One pharmacist at Newton-Wellesley Hospital outside Boston says the 240-bed facility is able to return some expired drugs for credit, but had to destroy about $200,000 worth last year. 

Play that out at hospitals across the country and the tab is significant: about $800 million per year. And that doesn’t include the costs of expired drugs at long-term care pharmacies, retail pharmacies and in consumer medicine cabinets.

It turns out that the FDA, the agency that helps set the dates, has long known the shelf life of some drugs can be extended, sometimes by years.

Taibbi on Republicans and Democrats Blocking Drug Reimportation

The one true bipartisan instinct in Washington? Caving to rich industries.

www.rollingstone.com

Drugs that are in fact very cheap to make are kept artificially expensive – we have drugs that cost $1,000 a pill here in America that sell for $4 in India, for instance.

The means of keeping prices high vary, but include lengthy patents to push production of generics into the future, the barring of foreign competition (usually on "safety" grounds), and the prohibition of negotiations to lower prices for bulk purchases by both the federal and state governments. Without government intervention, the pharmaceutical industry would be profitable, but it wouldn't be the massive cash factory it is now. In 2015, for instance, the 20 largest drug companies made a collective $124 billion in profits.

But we already do import foreign drugs, and have an established safety certification process. In fact, an astonishing 40 percent of all pharmaceuticals sold in the United States are already imported, as are 80 percent of the chemical ingredients. These imported drugs and drug ingredients arrive by way of more than 300,000 foreign food and drug manufacturing facilities that are regularly certified as safe by the FDA.

Drug reimportation would be a no-brainer policy move if actual human beings ran our government. Disgust with high prescription drug prices is nearly universal – 77 percent say drug prices are "unreasonable" – and 71 percent of respondents favor allowing the importation of cheaper drugs from Canada.

Back in January, Sens. Bernie Sanders and Amy Klobuchar introduced an amendment to a budget resolution that would have paved the way for drug importation. Twelve Republicans, including John McCain, Rand Paul and Lisa Murkowski, voted for it. But the measure died when thirteen Democrats voted no.

Social media slammed the 13 Dems, who included Mark Warner of Virginia, Chris Coons of Delaware, and Cory Booker and Bob Menendez in New Jersey (a New Jersey senator voting against big pharma is as rare as an Iowan voting against ethanol, which makes it more notable that Booker later came around on the issue).

Virtually every Trump nominee who would have influence over the importation question was bluntly opposed to the idea.

His FDA chief, Scott Gottlieb, was not only against importation, he'd written a Forbes editorial in 2016 denouncing then-candidate Trump's position on the issue. Trump's Health and Human Services chief, Tom Price, also has a long history of supporting pharmaceutical industry initiatives. Price's former press secretary, Ellen Carmichael, is now president of a political research firm called the Lafayette Company and just a few weeks ago was penning an anti-importation editorial reprinted by the Partnership for Safe Medicines, a leading industry group lobbying against reform.

"Filling the tree" is one of a whole range of tricks that exist in both the House and the Senate to save members from themselves – i.e., from having to vote on issues they know would be popular with people, but unpopular with their donors.

That's not to say it will happen in the case of this issue, but that it does frequently with "populist" ideas. People like McConnell stay in leadership thanks in large part to their demonstrated skill at saving members from having to vote down ideas they know their constituents want.

1. Clinton, Hillary (D) - $2,069,203
2. Burr, Richard (R-NC) Senate - $426,181
3. Ryan, Paul (R-WI) House - $395,174
4. Portman, Rob (R-OH) Senate - $388,896
5. Murray, Patty (D-WA) Senate - $340,644
6. Paulsen, Erik (R-MN) House - $334,900
7. McCarthy, Kevin (R-CA) House - $323,650
8. Blunt, Roy (R-MO) Senate - $318,984
9. Trump, Donald (R) - $296,877
10. Shimkus, John M (R-IL) House - $295,940
11. Toomey, Pat (R-PA) Senate - $295,026
12. Bennet, Michael F (D-CO) Senate - $294,317
13. Young, Todd (R-IN) House - $293,950
14. Rubio, Marco (R-FL) Senate - $283,771
15. Cruz, Ted (R-TX) Senate - $282,364
16. Pallone, Frank Jr (D-NJ) House - $267,376
17. Schumer, Charles E (D-NY) Senate - $265,161
18. Sanders, Bernie (D) Senate - $264,969
19. Brady, Kevin (R-TX) House - $257,451
20. Scott, Tim (R-SC) Senate - $243,350

Why Did Trump's Top FDA, Balaji Srinivasan, Pick Delete All His Tweets?

Balaji Srinivasan—a man who is reportedly Trump’s top pick to lead the FDA—has deleted all but one of his thousands of tweets. Normally, that might just seem like a smart move but with the Tweet-happy, shame-proof Trump administration it raises alarm bells.

gizmodo.com|Rhett Jones

You can see many of them on the Wayback Machine, which last logged his tweet count at 11,000. Google has also cached many of them and others can be found at this archive.is page.

Aside from their shared history in tech, O’Neill and Srinivasan are also well-known business associates of Trump’s science and technology advisor, Peter Thiel. Neither of the candidates have a significant medical background, breaking with 50 years of history for the agency’s heads.

Srinivasan co-founded the bio-tech firm Counsyl Inc. which specializes in DNA tests and pregnancy screenings to detect Down syndrome and chromosome-related birth defects. The biggest theory that people are floating for the entrepreneurs decision to delete his account is because he hates the FDA and has been vocal about it for years. He hates it in a burn-it-to-the-ground sort of way, not just a let’s-fix-some-problems sort of way.

For libertarian-minded folks like Theil, O’Neill and Srinivasan, the FDA simply functions as a way to stop companies from innovating.

“Exit” is a word that Srinivasan likes to say a lot. His particular brand of libertarian ideals is mostly about leaving the billionaires alone to do what they like and everyone should just become a billionaire. He even wrote an essay arguing that Silicon Valley should “build an opt-in society, ultimately outside the U.S., run by technology.”