"This is the information age," US Senator Lamar Alexander has informed the luddites in the executive branch.
Not through a text or a tweet, but in an old-fashioned letter to Department of Health and Human Services Secretary Kathleen Sebelius, Alexander questions how come some of the centers under her stewardship are more hip to this reality than others (ahem, FDA?). "Individuals should have direct access to personal health information, and federal policies should clearly support that goal," he wrote.
Alexander points out that the Centers for Medicare & Medicaid Services earlier this year issued a final rule in which it amends the Clinical Laboratory Improvement Amendments of 1988 so that labs regulated under these rules may provide patients with copies of their test reports upon request. This rule is in "direct conflict," according to Alexander, with FDA's decision to regulate 23andMe because the agency doesn't "trust individuals with test results." The senator goes on to ask Sebelius to account for this inconsistency in healthcare policy.
As far as the FDA is concerned, the agency's regulation of 23andMe falls squarely within its congressional mandate to protect and promote the public health through the regulation of food, drugs, and devices. Moreover, the agency has not restricted companies from selling people reports that contain their DNA readouts. The FDA has, to date, asked 23andMe to establish that it is accurately interpreting what those raw test results means in terms of people's health.
In a recent interview with PGx Reporter, FDA officials explained the agency's stance on public access to healthcare data … once again. But this being the Information Age and all, a lot gets lost in the chatter. And if there is one thing Alexander can't stand, it's chatter.
During last year's politically hostile legislative environment, the conservative from Tennessee found comity with democratic Senator Dianne Feinstein in co-sponsoring a bill that would ban verbal cell phone conversations on airplanes. According to a statement from Alexander, while the Commercial Flight Courtesy Act would still permit texting, it would restrict fellow passengers from "babbling" on their phones about their "love life [and] bathroom plans." Even in the information age, that's TMI.