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23andMe is first with FDA-authorized direct-to-consumer genetic test

By Rachel A. Hardy, MA, RAC

The company 23andMe has recently found favor with the U.S. Food and Drug Administration. On 19 Feb 2015, the agency announced it had issued marketing authorization for the company’s Bloom Syndrome carrier test, which determines whether healthy adults carry a gene variant that could cause a serious disorder in their offspring (FDA 2015a).

This marketing authorization is significant for two reasons. It marked the first time FDA had authorized a direct-to-consumer genetic test. In addition, the authorization holder, 23andMe, received an FDA warning letter in 2013 for failing to obtain marketing clearance or approval for the 23andMe Saliva Collection Kit and Personal Genome Service (PGS) (FDA 2015a, FDA 2013). As a result, 23andMe suspended its genetic testing services except for purposes of determining ancestry (Hardy 2014).

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Compounder’s Choice: Pharmacy or cGMP

By Rachel A. Hardy, MA, RAC

On 27 Nov 2013, the Food and Drug Administration gained new tools to regulate drug compounding when President Barack Obama signed the Drug Quality and Security Act (DQSA). In this legislation, Congress addressed longstanding questions of the FDA’s jurisdiction over compounding pharmacies, which are licensed by the states (US House of Representatives 2013a).

Tragic events prompted Congress to act. An outbreak of fungal meningitis in late 2012, which took a toll of more than 60 deaths and at least 750 sickened in 20 states, was traced back to an injected steroid produced by the New England Compounding Center (NECC), a compounding pharmacy that was licensed by the Massachusetts Board of Registration in Pharmacy (US CDC 2013).

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RAPS Changes RAC Requirements

By David Jensen, PhD RAC

The Regulatory Affairs Professional Society (RAPS) has announced changes to their Regulatory Affairs Certification (RAC) requirements (read the Regulatory Focus article). Essentially, the RAC has new eligibility requirements, a new fee structure, and some minor changes to the re-certification deadlines and process.

The biggest change comes in the eligibility requirements. Starting with the Fall 2014 exam period, RAPS will require a person seeking the RAC credential to have BOTH a college degree (Bachelors or above) AND (currently this is “or”) some number of years of professional regulatory or related healthcare product experience. There is no definition given for “related healthcare product experience” nor which experience is valid and which is not. The minimum number of years of required experience depends on the level of education (Bachelors = 3 yrs; Masters = 2 yrs; Doctorate = 1 yr).

The new fee structure for the exam simplifies the registration process. No longer will there be early and late registration dates plus member/non-member rates. Now, RAPS members will pay $425 and non-members will pay $525 to take the exam. Additionally, there are new registration deadlines: March 1st for the spring exam cycle and September 1st for the fall cycle.

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