FDA formally posts testing advisory after town hall discussion

The U.S. FDA said in a Jan. 8 press release that molecular testing for the SARS-CoV-2 virus can return false negative results if the test is applied to the so-called B.1.1.7 variant of the virus. The B.1.1.7 variant, first identified in the U.K., has been detected in the U.S., and the agency indicated that the risk that this and other mutations will impact overall test accuracy is low. Still, the agency is working with test developers and has undertaken an analysis of this variant to establish whether existing tests will be affected by the mutation. The mutation appears to have had little impact, if any, on the sensitivity of several tests that check for multiple targets on the pathogen’s surface. Clinicians and clinical lab staff are advised to reexamine test instructions, which in some instances have been edited to account for the mutations. The question of the B.1.1.7 variant was addressed in the Jan. 6 FDA diagnostic town hall.

HHS finalizes regulatory review rule

The U.S. Department of Health and Human Services (HHS) finalized a rule that requires its agencies to periodically examine any rules implemented 10 or more years in the past to evaluate whether those rules should be modified or withdrawn. The rule reflects an interpretation of the Regulatory Flexibility Act of 1980, which was in turn an amendment to the Administrative Procedures Act, which was signed into law in 1946. HHS said the 10-year review rule is intended to ensure that the department’s regulations “are having appropriate impacts and have not become outdated,” although some special emphasis is placed on the impact on small businesses. Much of the concern revolving around current approaches to regulatory review hinge on the fact that economic cost-benefit analyses are conducted only upon the publication of the draft rule, and that such analyses conducted post-implementation could shed a less favorable light on those benefits and costs. HHS noted in a Nov. 4, 2020, press release that an analysis of existing rules conducted by artificial intelligence indicates that 85% of all HHS rules finalized before 1990 have not been edited. Each U.S. president going back to Jimmy Carter has issued rules pertaining to periodic review of regulations, including executive order 13563 by the Obama administration, which called for a review of existing significant regulations for potential modification “or repeal … in accordance with what has been learned” regarding the function of those rules. The incoming Biden administration presumably has the authority to rescind this rule.

Lab in California hit for three months of false claims

The U.S. Attorney’s Office for the District of New Jersey said Exceltox Laboratories LLC, of Irvine, Calif., will pay more than $357,000 to settle allegations of violation of the False Claims Act in connection with billings to the Medicare program for genetic testing without physician oversight. Over a three-month period in 2015, Exceltox entered into a marketing contract with MD Global, which in turn had employed the services of Seth Rehfuss and Good Samaritans of America to assist in the contract between Exceltox and MD Global. Rehfuss is alleged to have recruited senior citizens in New Jersey to submit to genetic testing without a prescription. Rehfuss, of Somerset, N.J., entered a guilty plea in May 2019 in a related matter, which resulted in a prison sentence of 50 months. Exceltox has admitted no wrongdoing and there was no finding of liability in connection with the settlement.

BVMed calls for German med-tech strategy

The Federal Association of Medical Technology (BVMed), has argued for development of an overall strategy for the med-tech industry in Germany that would more firmly link health and economic research. The related paper (in German) describes Initiative MedTech 2030 as calling for establishment of a med-tech innovation agency and more access to care data for domestic industry. This paper will be used to inform the policy positions of candidates in Germany’s federal elections later this year. Among the areas of emphasis spelled out in the paper are reduced government agency hurdles and a promotion of digital services, telemedicine and artificial intelligence. The association also would emphasize mid-sized med-tech firms in Germany, noting that 90% of the 235,000 citizens of Germany employed in med tech work for medium-sized firms. BVMed also argued for a 10% R&D tax credit.