23andMe May Be On the Chopping Block

You may have been following the FDA's crackdown on genetic testing company 23andMe.  I know that I have been, as one of over 500,000 individuals who have purchased 23andMe's Personal Genome Service. Anecdotally, I have recommended 23andMe to many friends and colleagues - I really enjoyed seeing my ancestry, risk of disease, and learning more about my DNA.

[23andme.com]

In May, the FDA asked 23andMe, a Google-backed company, for more information about their genetic testing service. When the company failed to reply, last week the FDA ordered 23andMe to stop marketing its genetic test because it said the company has not provided adequate evidence that the tests were accurate. In its warning, the FDA further expressed concerns that patients receiving genetic information without medical guidance might seek unnecessary, and possibly harmful, medical testing or treatment. Interestingly, the FDA's warning letter does not mention that it has received any customer complains about 23andMe's service.

Until this week, 23andMe had not provided comment about the FDA warning letter that leaked  last week. On Tuesday night,  23andMe co-founder Anne Wojcicki finally spoke out. Wojcicki admitted that she failed to respond to the FDA's concern and highlighted a problem with the FDA's approval system. The agency, she said, "is set up to approve individual tests, but 23andMe tests about a million components of a person's DNA. Filing for a million approvals would be impossible."

CLIA Certification

[darkdaily.com]

In addition to needing FDA approval for its genetic tests, 23andMe also had to obtain Clinical Laboratory Improvement Amendments (CLIA) certification from The Centers for Medicare and Medicaid (CMS). All lab testing performed on humans must have CLIA certification. The CLIA Program sets standards for these labs and assigns scores 1, 2 or 3 for each of the following criteria:

1. Knowledge
2. Training and experience
3. Reagents and materials preparation
4. Characteristics of operational steps
5. Calibration, quality control, and proficiency testing materials
6. Test system troubleshooting and equipment maintenance
7. Interpretation and judgment

Click here for more information on CLIA Law & Regulation.

Friday Variety: NO Smoking and MORE Abortion News

On Tuesday, the FDA finally stood up to the Tobacco industry.  Four years ago, President Obama signed a tobacco bill granting the FDA authority to exercise its power to regulate cigarettes and other tobacco products.  

Under the law, the F.D.A. is able to set product standards and ban some chemicals in tobacco products, but not totally ban addictive nicotine. The F.D.A. also set up a new tobacco regulatory office financed by industry fees, which totaled $85 million in the first year and as much as $700 million annually within 10 years.
The F.D.A. has had the power not only to consider changing existing products, but also to ban new products unless the agency found they contributed to overall public health. 

Exercising this power, the FDA has allowed two products to be sold - metholated versions of Newport cigarettes - and rejected four others.  According to the LA Times "Science Now" blog, "those products, which the FDA is legally forbidden to identify, raised questions of public health that have not been substantially answered by studies of existing products."

The FDA has stated it will continue to allow more products if they are similar enough to ones already on the market.

Abortion, again?

Delaware, North Dakota and Texas all made headlines this week for their abortion law efforts:

Delaware: In a unanimous vote, the Delaware Senate aproved a bill (discussed here last Friday) that more tightly regulates abortion clinics. The measure will now go the House.

North Dakota: On Tuesday, a women's rights group filed a lawsuit in Federal court to bock a North Dakota ban on abortions. The ban makes illegal abortions as early as six weeks into pregnancy, a law the New York Times calls "the country's most stringest abortion law." The law, enacted in March, forbids abortions once a fetal heartbeat is "detectable."  This can be as early as six weeks and even before many pepole know they are pregnant.  The complaint states that the law seeks "to interfere directly in personal, private medical decisions that the Constitution and more than 40 years of US Supreme Court precedent guarantee to women as a fundamental right."

Texas: After the widely publicized and acclaimed fillabuster by Wendy Davis, a Democratic senator, Texas Governor Rick Perry called the state legislature back in session July 1 to give state lawmakers another chance to pass a measure that may close most of the state's abortion clinics.

Blinding FDA Approval

Final Score:

Generic Drug Industry - 1

Consumer Safety - 0

 In a 5-4 Opinion announced this Monday, the Supreme Court ruled that as long as the brand-name version of a drug receives FDA approval, the generic manufacturers of the same treatment cannot be sued for the drug's design defects in state court.

The ruling overturned a $21 million jury award to Karen Bartlett, a New Hampshire woman who suffered severe burns and lost nearly all of her eyesight after she began taking Mutual Pharmaceutical's generic version of Merck's nonsteroidal anti-inflammatory drug, Clinoril (sulindac), for shoulder pain.

Also released on Monday was a study by Public Citizen which found that current FDA regulations "do not adequately allow for generic drug manufacturers to update their labels if new dangers are revealed once a drug is on the market." The study added that there are at least 52 FDA-approved medications that have "required new warnings for serious or life-threatening risks in the last 5 years." Since generics account for 80% of all prescriptions filled last year, Public Citizen urged the FDA to "allow drug producers to report updated safety information." This reporting would ensure warnings are up to date and also correct a disparity in legal rights for consumers.

So now's the time Congress to re-evaluate the protections given to generic drug manufacturers. And they better do it now, or there will be more Karen Bartletts to come.