U.S. Senators: More protection needed for genomic data | 2021-02-01

Citing “troubling reports” about Beijing Genomics Institute’s (BGI) efforts to “exploit the pandemic to expand their reach within the United States,” Sens. Marco Rubio (R-Fla.) and Chuck Grassley (R-Iowa) are calling on the U.S. Health and Human Services (HHS) Office of Inspector General (OIG) to expand the scope of an ongoing audit aimed at better protecting Americans’ genomic data.

The senators said that HHS had obtained BGI COVID-19 test kits through a friendly country and then distributed them to states without realizing their origin.

“In light of the documented concerns from the intelligence community and the ongoing investigation into HHS’s national security protocols, it is unacceptable that safeguards were not in place to prevent HHS’s promotion of BGI products,” the senators said, noting BGI’s ties to the Chinese government and what they described as its human rights abuses.

In a February 2019 report, HHS OIG released a report that included an FBI warning identifying the department’s lax genomic data-sharing practices and China as a risk to the security of genomic data. Subsequently, OIG began auditing the Centers for Medicare & Medicaid Services’ assessment of national security risks to genomic testing data.

To protect Americans’ genomic data, the senators asked the HHS OIG to broaden that audit to include a review of the department’s actions regarding BGI during the pandemic. They also asked for recommendations on how to strengthen HHS’ national security practices.

Veterans’ genomic data put at risk

The U.S. Veterans Administration (VA) Office of Inspector General found that two VA employees made false statements and concealed material information in the approval of a 2016 research collaboration with Flow Health that would have given the Los Angeles-based diagnostics company all the health records of every veteran treated through the VA, past and future, including the genomic information of veterans maintained by VA’s Million Veteran Program.

Under the cooperative research and development agreement, the VA health data would have been used along with Flow Health’s deep learning and artificial intelligence resources to discover evidence to prevent illness, improve diagnoses and identify personalized treatments, according to a Jan. 28 report from the VA OIG.

Despite warnings from VA privacy experts about serious privacy issues that needed to be addressed before the agreement could be approved, the two employees told the approving official that all the privacy, information security and legal reviews had been completed and implied that any concerns had been addressed. Media reports about the contract resulted in it being cancelled two months after it was awarded – and before any data was given to Flow Health.

As a result of the two employees’ actions, “the health data of tens of millions of veterans would have been placed at risk of disclosure had the contract not been cancelled,” the VA OIG concluded.

DNA sequencing claims struck down

In a decision handed down Feb. 1, the U.S. Court of Appeals for the Federal Circuit agreed with the Patent Trial and Appeal Board that claims in five patents granted to New York-based Columbia University involving nucleotide analogs and a method of using those analogs to sequence DNA are invalid due to obviousness.

The method claimed is known as sequencing-by-synthesis, which works by detecting the identity of a nucleotide analogue after it is incorporated into a growing strand of DNA.

The appeal primarily centered on one aspect of the claims: the use of a small “allyl capping group” that is not ketone, methoxy or ester. The court noted that, according to Columbia, “the inventors discovered that a capping group should have these characteristics in order to ‘work for SBS.’”

In its inter partes review challenge of the claims, Illumina Inc., of San Diego, asserted that certain combinations of prior art made the use of a labeled nucleotide analog with an allyl capping group obvious.

More BREXIT guidance

As part of its BREXIT guidance, the U.K. Medicines and Healthcare Products Regulatory Agency (MHRA) issued guidance Feb. 1 setting out the submission dates for the next year for the 150-days assessment procedure for national marketing authorization applications involving new active substances.

The submission deadlines align with the meeting dates of the Commission on Human Medicines.

The guidance also explains the European Commission (EC) decision reliance procedure, which can be used for new drugs as well as generics. Under the procedure, applicants may seek a Great Britain marketing authorization that relies on a centralized EC marketing authorization for the same product.

In a separate guidance issued Feb. 1, the MHRA updated its guidelines pertaining to a company’s qualified person responsible for pharmacovigilance and pharmacovigilance system master files.

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