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This Week in FDA Regulations: 23andMe, Drugs, Antibiotics in Meat

By William Peacock, Esq. on December 12, 2013 | Last updated on March 21, 2019

It's been awhile since our last FDA round-up, so there's plenty to talk about.

Selling genetics tests without prior FDA approval? That's a paddlin'. And speaking of FDA approval, two drugs recently approved by the agency, one for Hepatitis C, and one for pain, are receiving opposite reactions from the public. And finally, antibiotic-free meat production may in our nation's future. Maybe.

Curious? Read on.

23andMe: This is a Medical Device. You Need Approval.

The FDA came down hard on genetic-testing startup 23andMe this month, sending them a warning letter last month that accused them of marketing an unapproved medical device. The tests screen for genetic markers for diseases such as diabetes, coronary heart disease, and breast cancer, and provide information on ancestry, and in the FDA's opinion, the "heath reports" provided bring the tests under the FDA's jurisdiction.

It's hard to get mad at the FDA here. While 23andMe is a brilliant idea, providing preventative health information at a low cost to consumers, and providing "big data" of genetic markers in the population as a whole for medical research, the FDA apparently explained to them on numerous occasions that approval was required.

Last week, the company, which has stopped selling the tests for now, told Venture Beat that it intends to seek FDA approval, and that it was not going anywhere. (Indeed, with billionaire backers, including the founder's soon to be ex-husband, Sergey Brin, of Google, there's probably plenty of cash on hand to stay afloat.)

Hepatitis C Drug? Yay. Super Powerful Pain Pill? Nay.

Two drugs recently approved by the FDA have inspired very different, and very vociferous commentary.

Sovaldi (Sofosbuvir) is a Hepatitis C treatment that does not require the use of side-effect heavy interferon. Instead of crippling treatment for an incurable disease, this once-a-day pill promises to block a protein that the virus needs to replicate.

Why is this a big deal? Besides the lessening of side effects, more than 3.2 million are estimated to have chronic hepatitis C. Last year, the CDC asked all baby boomers, between the ages of 48 and 68, to be tested, as they believe there may be another 800,000 or so who are undiagnosed, reports Forbes.

Meanwhile, a additive-free hydrocodone formulation, Zohydro, is inspiring the opposite reaction, with 28 state attorneys general writing to the FDA to ask them revoke their recent approval.

Why? Hydrocode is the most prescribed drug in America, it is a highly addictive and often abused opiate. The DEA ranks it amongst the most abused medicines in America. And while most formulations are diluted with milder drugs, such as acetaminophen (Tylenol), this variant is 5 to 10 times as powerful as existing recipes, reports The Associated Press.

Clean Meat?

The last stop on the FDA roundup comes on the cattle farms, where the FDA is hoping that a voluntary compliance program will lead drug manufacturers and meat producers to stop pumping their animals full of antibiotics, except when medically necessary.

Why? The drugs at issue are often used to treat humans. The more they are used on livestock and turkeys, the more resistant bacteria become. By using them as a preventative (and growth-inducing) measure, meat producers are weakening a medicine used by humans.

Critics, in Congress and at the National Resources Defense Counsel, want the program to be less voluntary, reports the Los Angeles Times. But the FDA defended their action, noting that a mandatory program would lead to costly litigation. Plus, if companies refuse to participate, the FDA can always take additional action down the line.

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