Tag Archives: FDA

The FDA and its regulation of genetic data purchased by Americans

Link here. The article is a detailed history of the company 23andMe, which offers individuals a way to get their personal genetic data. The company was growing and flourishing, providing data to its customers, until the FDA stepped in.

In 2009, the FDA started asking 23andme for evidence that the company’s products worked as advertised and wouldn’t harm customers. The agency was worried that people might take drastic medical measures on the basis of their test results, such as deciding to change the dosage of their medications without consulting a doctor or undergoing unnecessary surgery, such as a mastectomy, or treatment based on false positives. Regulators demanded evidence that the tests were accurate, and that customers were well informed what the results meant.

The next years were difficult ones for 23andme. It communicated with the agency on a few occasions and promised in January 2013 that data would be forthcoming. According to the FDA, it then ceased communicating with regulators entirely in May, even as it started a new advertising campaign. Fed up, the agency sent [Anne] Wojcicki [company CEO] a strongly worded warning letter on 22 November 2013 ordering her company to stop marketing its product.

It was a self-inflicted wound for the company. “There was a bit of arrogance,” says Richard Scheller, who was an executive at Genentech at the time. As a result, 23andme was forced to drastically cut its customer offerings, threatening its viability.

Wojcicki was stunned. “It became clear that we had pissed them off,” she says. “I really didn’t know that we had done so many things that angered them.”

Soon after the letter arrived, Wojcicki called Kathy Hibbs, a lawyer then working for Genomic Health, a gene-testing company in nearby Redwood City, California. “Can I get my whole company back in one year?” Wojcicki asked Hibbs.

“You can get it back, but it will take years,” Hibbs replied. And to get there, she counselled, Wojcicki would have to cooperate with regulators.

It was a tough adjustment for Wojcicki; she didn’t think that the FDA should be able to stop customers from learning their own genetic information. But Hibbs and others convinced her that capitulating to the FDA’s demands was the fastest way to rescue her company. [emphasis mine]

The FDA’s high and mighty attitude here really offends me. It appears that before and after their demands, nothing really changed. All that had happened was that a government agency took control of a private company’s operation, coming between it and its customers. Right now it limits the data that the company can release to its customers, the people that pay for the service in order to obtain their own genetic data.

In other words, the FDA doesn’t think ordinary people are smart enough to see their own data. If that doesn’t capture the arrogance of government, I don’t know what does.

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Government to ban cheese

We’re here to help you: New FDA regulations will make the import of certain very well known European cheeses forbidden.

New FDA restrictions on the levels of harmless bacteria found in imported cheese have effectively banned a number of artisan French cheeses, including Roquefort, Morbier, and Tomme de Savoie. The restricted bacteria already exist in the human stomach, and the banned cheeses have not changed their recipes for years. [emphasis mine]

Why is the FDA wasting time banning French cheeses when the deadly bacteria can be found in the human stomach? Shouldn’t the FDA instead ban the human stomach?

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More forgotten vials of deadly diseases discovered

FDA officials now admit that when they discovered six undocumented vials of smallpox in a facility in Maryland they also found 327 additional vials that contained dengue, influenza and rickettsia.

FDA scientists said they have not yet confirmed whether the newly disclosed vials actually contained the pathogens listed on their labels. The agency is conducting a nationwide search of all cold storage units for any other missing samples.

Investigators destroyed 32 vials containing tissue samples and a non-contagious virus related to smallpox. Several unlabeled vials were sent to the Centers for Disease Control and Prevention for testing and the remaining 279 samples were shipped to the Department of Homeland Security for safekeeping.

The FDA’s deputy director is quoted with what might be the understatement of the year. “The reasons why these samples went unnoticed for this long is something we’re actively trying to understand.” You think so, eh?

Let’s just make a quick list of the alphabet soup of federal agencies that we have discovered in the last few months to be either corrupt, incredibly incompetent, or spendthrifts: FDA, CDC, IRS, VA, HHS, NIH, GAO, DHS, TSA. We can add the State Department for its wonderful work in Benghazi, as well as the Border Patrol for their stellar effort in securing the border. I also know that the management at NASA leaves much to be desired.

We can also be sure that this is a partial list. It suggests something that any reasonably intelligent person should quickly see: The federal government is a corrupt mess, and should be overhauled so aggressively that when we are done we shouldn’t recognize it anymore. Certainly its size should be slashed by half, if only to cut off the excess funds that are being funneled to an uncountable number of corrupt practices.

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The Obama administration has been caught tracking the emails of a group of scientists critical of certain FDA actions.

George Orwell would be proud! The Obama administration has been caught reading the emails and personal files of a group of scientists who were critics of the FDA.

The agency, using so-called spy software designed to help employers monitor workers, captured screen images from the government laptops of the five scientists as they were being used at work or at home. The software tracked their keystrokes, intercepted their personal e-mails, copied the documents on their personal thumb drives and even followed their messages line by line as they were being drafted, the documents show.

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Six former and current employees have sued the FDA agency under the Obama administration over its secret surveillance of their private emails.

How Obama encourages transparency: Six former and current employees have sued the FDA agency under the Obama administration over its secret surveillance of their private emails.

According to a release by the law firm representing the group, the FDA targeted the employees with a “covert spying campaign” that lasted for two years after it learned they had written a letter to President-Elect Obama in early 2009. … The plaintiffs allege the agency used spyware to read the their personal emails and take screenshots while they used government computers. But whether such reconnaissance is illegal is not quite clear. According to the Washington Post, “the startup screen on FDA computers warns employees, ‘you have no reasonable expectation of privacy,’ ” including any communication accessed or sent from the machine.”

According to the law firm representing the current and former FDA employees, the monitoring continued even after the Health and Human Services Office of Inspector General “denied the FDA’s request to take any criminal and/or administrative action against the whistleblowers” and noted the whistleblowers’ communications with Congress were protected under law.

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