Free Republic

Almost two years after Texas tried to import an execution drug from overseas, the U.S. Food and Drug Administration ruled Thursday that the drug can’t be admitted into the United States. In July 2015, the Texas Department of Criminal Justice tried to import 1,000 vials of sodium thiopental, an anesthetic that the state has previously used in executions, but the FDA seized the drugs at a Houston airport and has held them ever since. The federal agency has maintained that the import of the drug is illegal because it is not currently approved in the U.S. In a statement, the...

One day in late spring in the early days of the George W. Bush administration, FDA inspectors visited the headquarters of Sargento cheese in Plymouth, Wisconsin—a routine visit as part of the federal government's efforts to ensure the safety of the food we eat. The inspectors took samples of cheese to test for bacteria. Sargento conducted tests on cheese from the same lot. A week later, the results from both sets of tests were in—the cheese was bacteria-free. Sargento, having gotten the all-clear from the government, shipped the cheese to stores across the country. Two months later, however, the FDA...

According to a U.S. Food and Drug Administration statement released Friday, Evanger’s, a family-owned and -operated cat and dog food business, decided to voluntarily recall five lots of the product – all of the Hunk of Beef products that were manufactured that same week. The products were distributed to retail locations and sold online in these states: Washington, California, Minnesota, Illinois, Indiana, Michigan, Wisconsin, Ohio, Pennsylvania, New York, Massachusetts, Maryland, South Carolina, Georgia and Florida. Hunk of Beef is Evanger’s best-selling food. Pets nationwide consume more than one million cans of the product each year, the company said in a...

As someone who has written about FDA reform for many years it’s gratifying that all of the people whose names have been floated for FDA Commissioner would be excellent, including Balaji Srinivasan, Jim O’Neill, Joseph Gulfo, and Scott Gottlieb. Each of these candidates understands two important facts about the FDA. First, that there is fundamental tradeoff–longer and larger clinical trials mean that the drugs that are approved are safer but at the price of increased drug lag and drug loss. Unsafe drugs create concrete deaths and palpable fear but drug lag and drug loss fill invisible graveyards. We need an...

Of the fifty-one thousand products introduced since 1994, only 170 (0.3 percent) have any documentation of their safety Americans spend more than $32 billion a year on more than 85,000 different combinations of vitamins, minerals, botanicals, amino acids, probiotics, and other supplement ingredients. 1 While it costs millions of dollars to develop and substantiate a pharmaceutical product, selling supplements requires no such investment. And new products are easily sold as supplements. The only common feature among them, as defined by the FDA, is that these are edible things not intended to treat, diagnose, prevent or cure diseases. However, this is...

Safety: Shortly after the Surgeon General denounced e-cigarettes as a terrible public health threat to young people, a national survey showed that his fears are misguided, and his proposed "remedies" could cause more harm than good. The definitive Monitoring the Future survey found that "vaping" rates among teenagers dropped sharply between 2015 — the first year the survey asked about e-cigarette use — and last year. The share of high school seniors who reported vaping in the previous month, for example, went from 16.3% to 12.5%. At the same time, smoking rates among teens continue to fall. Just 10% of...

There is persistent tension over the issue of drug regulations. On one side are those who think that before we sell drugs to the public with health claims, we should ensure there is a reasonable amount of objective quality scientific evidence to demonstrate that the drugs are safe and effective. I admit this is the side of the discussion on which I fall... The other perspective is that requiring too much research and regulation slows the passage of potentially new and lifesaving drugs to the public. Potentially useful drugs should be fast tracked as much as possible. In the extreme...

Regulations: An easy way to tell whether one of Donald Trump's leadership picks is a good one is to gauge the freakout level among the left. By that measure alone, the person Trump is considering as head of the Food and Drug Administration would be an outstanding choice. Jim O'Neill, whose name got floated this week, is a managing director at of Trump pal Peter Thiel's Mithril Capital Management. In addition to private sector experience, O'Neill worked at the Department of Health and Human Services under President Bush. But he's also — gasp! — a libertarian! Thus, we're seeing headlines...

WASHINGTON—Passage of legislation aimed at speeding up Food and Drug Administration approvals, combined with an incoming president who has pledged to “cut red tape” at the agency, is expected to usher in a new, more industry-friendly era of drug and device regulation. The Senate on Wednesday cleared the measure known as the 21st Century Cures bill, which lays out in detail speedier and more pro-industry methods for the FDA to approve new drugs and medical devices. Its supporters, such as PhRMA, the drug-industry association, and AdvaMed, representing device makers, praise it as a way to bring about more innovation and...

<p>Theranos, the biotech company started by a 19-year-old Stanford dropout, has another hurdle to cross in its whole "we're totally a legit blood-testing company" campaign. This time, it turns out that tens of thousands of blood tests were voided, making them totally invalid. Whoops!</p>

We haven't really written much about the insane Theranos scandal, though we discussed it on our podcast. The whole story is pretty crazy -- involving a heavily hyped up company that appeared to basically be flat out lying to everyone about what it could do. The company still exists, but barely. The company's founder and CEO, who was plastered across magazine covers and compared frequently to Steve Jobs, has been banned from running a lab for two years, and the company is now facing a $140 million lawsuit from its biggest partner, Walgreens, who claims that Theranos repeatedly lied to...

Litigator David Boies and the law firm he founded, Boies, Schiller & Flexner LLP, have stopped doing legal work for Theranos Inc. after disagreeing about the strategy for handling ongoing government investigations of the blood-testing company, according to people familiar with the matter. Mr. Boies, 75 years old, has been one of the country’s best-known litigators since the late 1990s. He became Theranos’s outside counsel after being approached in 2011 by two investors in the Palo Alto, Calif., startup. He fiercely defended Theranos against questions about its technology and operations. Those efforts included threatening to take legal action against The...

Litigator David Boies and the law firm he founded, Boies, Schiller & Flexner LLP, have stopped doing legal work for Theranos Inc. after disagreeing about the strategy for handling ongoing government investigations of the blood-testing company, according to people familiar with the matter. Mr. Boies, 75 years old, has been one of the country’s best-known litigators since the late 1990s. He became Theranos’s outside counsel after being approached in 2011 by two investors in the Palo Alto, Calif., startup. He fiercely defended Theranos against questions about its technology and operations. Those efforts included threatening to take legal action against The...

It's worth asking why Elizabeth Holmes is still leading the embattled blood testing company Theranos Inc. But there may be a good reason why she still is in charge, one that has little to do with the scandal-ridden company's performance to date. Forget what venture capitalist Tim Draper — one of the first to invest in the Palo Alto company — implied this week that Holmes is being attacked because she's a young, female entrepreneur. The simple fact is that Theranos has not been able to deliver on its technology from a commercial, scientific or regulatory standpoint, and that falls...

2016 has not been too kind to Elizabeth Holmes, the Steve-Jobs wannabe in charge of fraudulent Theranos. She has thus far been banned for 2 years from operating labs, removed from hosting fundraisers for Hillary and lost her entire net worth. And now, the Wall Street Journal has published the "tell-all" story of the whistle-blower, 26 year old Tyler Shultz, who brought the the whole Theranos farce crashing down. It's a sordid tale complete with all the expected twists and turns of a Jason Bourne thriller including intimidation, coercion and private detectives. Tyler Shultz is the grandson of George Shultz,...

I am frankly shocked this information is not making front page news right now. Monsanto will do anything to bury this story… and as of right now, it’s working. Not a single mainstream media outlet has covered this appalling new report that shows millions of people being poisoned by a chemical that does not belong in our food. This chemical is ending up in processed foods like Cheerios, Ritz Crackers, and Oreos and being consumed by humans across the world. The health of millions of people is on the line and this news must go mainstream! That’s why I’m calling on every single one of you...

...In August a new FDA rule went into effect that forbids tobacco makers and distributors from handing out free samples. Some companies that have been donating cigars to service members for decades have now stopped for fear that this is now illegal... California Republican Duncan Hunter, who did combat tours in Iraq and Afghanistan before becoming a Marine reservist, says legislation shouldn’t be needed. In a Sept. 8 letter, he asked FDA Commissioner Robert Califf to clarify if the new rule really does ban cigar donations to soldiers. He’s still waiting to hear back.... The FDA’s bureaucrats are happy to...

Despite what many people think the left-liberal coalition’s decision to base so much of its effort on keeping the government out of our bedrooms is, long term, a losing strategy. Conservatives have a slight advantage where these issues are the only ones considered by people when deciding how to vote. If they could redirect their efforts to keeping government out of the kitchen they might have something. Uncle Sam has decided what we eat and drink is somehow his business. The government says it wants to bend the healthcare cost curve downward but really this is just another version of...

New Food and Drug Administration regulations on cigars, e-cigarettes and other products that took effect Aug. 8. Among the regulations is what many interpret as a ban on the charitable donation of tobacco products.

Presidential hopeful Hillary Clinton urged Mylan to voluntarily slash the prices of its products while promising that, once she’s elected, her “plan to address exorbitant drug price hikes like these” will be finally implemented. This is a particularly empty promise considering Mylan has donated between $100,000 and $250,000 to the Clinton Foundation, which was recently revealed to be peddling influence in exchange for cash. Senators Susan Collins (R-ME) and Claire McCaskill (D-MO) are also pressuring the manufacturer to disclose more about its pricing. Even Senator Joe Manchin (D-WV) — whose own daughter, Heather Bresch, serves as Mylan’s CEO — weighed...