The Sky is Falling for Personal Genomics! Oh, nevermind. It’s just a cease & desist letter from the FDA to 23andMe.

FDA v LDTGenomics Law Report has paid close attention to the FDA’s potential regulation of laboratory developed tests (or LDTs) over the years. We have decided to address the most recent development – a cease and desist letter sent by the FDA to 23andMe – in two posts — by Jennifer Wagner and by John Conley.

A brief background for the newcomers

23andMe, Inc. was founded in 2006. Its personal genomics service launched in 2007 and was named Time Magazine’s Invention of the Year in 2008. Just before the Thanksgiving holiday in 2009, 23andMe split its all-in-one service into two separate editions for ancestry and health and raised its price. The following year, just before the 2010 Thanksgiving holiday, 23andMe scratched its business model with separate health and ancestry editions in favor of a return to the all-in-one service with a new mandatory annual subscription fee. By June 2011, the company boasted 100,000 users and in late 2012 lowered its price to $99 to aim for one million users. Recently, 23andMe ramped up its marketing, launching its very first TV ad campaign called “Portraits of Health” in August 2013.

Company’s run-ins with the FDA

On June 10, 2010, the company—along with several other direct-to-consumer (DTC) providers—received a cease & desist letter from the FDA. A full two years later, on July 30, 2012, the company touted it was the first of its kind to
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Filed under FDA LDT Regulation, General Interest, Genomic Policymaking, Genomics & Medicine, Genomics & Society, Legal & Regulatory

Revisions to the Ethical Standards for Research

HelsinkiThe World Medical Association published revisions to the Declaration of Helsinki (DoH) in JAMA on October 19, 2013. As noted previously on the Genomics Law Report, the DoH was adopted in 1964 and is considered a foundational guiding document for ethical medical research. The DoH has been revised six times previously, and these are the first revisions since 2008. The revised DoH was announced following the Working Group’s public consultation from April to June 2013 on the text of proposed changes, though the Working Group has apparently spent at least two years contemplating revisions and consulting with experts. In the United States, the DoH has been an important foundational document promoting the creation of institutional review boards (IRBs) but has had relatively little practical influence since it was effectively abandoned by the administration of former President George W. Bush. Nonetheless, the DoH continues to exert significant influence over international ethical standards.
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Filed under Genomic Policymaking, Genomics & Medicine, Genomics & Society, Informed Consent, International Developments, International News

Genomic Research Ethics: Special Rules for HeLa Cells

In her 2010 book The Immortal Life of Henrietta Lacks, Rebecca Skloot told the story of Henrietta Lacks and the cell lines derived from her cervical tumor biospecimen (cell lines known to scientists simply as “HeLa cells”). To make a long story short, in 1951 physicians at Johns Hopkins Hospital took a biopsy from a patient, Henrietta Lacks, and from that biospecimen developed the first human cancer cell line. The biospecimen was taken without Lacks’ knowledge or informed consent. No laws were broken in the creation of the HeLa cell lines that are now recognized (pdf) as “the most widely used human cell line in the world.” She died in 1951, and it was reportedly not until 1973 that her family learned about the HeLa cells (two years after Henrietta Lacks’ name was published as the source of HeLa cells in a scientific journal). As the table below shows, this incident occurred long before the adoption of regulations and ethical guidelines for biomedical research that, today, generally require researchers to obtain voluntary, informed consent from individuals before performing biomedical experiments.
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Filed under Genetic Testing/Screening, Genomic Policymaking, Genomics & Medicine, Genomics & Society, Informed Consent, International Developments, Pending Regulation, Privacy

Ninth Circuit Orders Rehearing of Haskell v. Harris

1037193_dna_fingerprint_5When the Supreme Court issued the Maryland v. King opinion on June 3, 2013 upholding Maryland’s DNA Collection Act, numerous cases were pending in which similar DNA fingerprinting upon arrest statutes in other jurisdictions were being challenged. The dissenting justices encouraged cases to press forward and give the Court an opportunity to change its current Fourth Amendment course, with Justice Scalia writing, “I … hope that today’s incursion upon the Fourth Amendment, like an earlier one, will some day be repudiated.” It was only a matter of time for us to see just what the impact of the Maryland v. King decision will be.
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Filed under General Interest, Genomics & Society, Privacy

Approved North Carolina State Budget Includes Funds to Compensate Sterilization Victims

Jennifer K. Wagner, J.D., Ph.D., is a solo-practicing attorney in State College, PA and a research associate at the University of Pennsylvania’s Center for the Integration of Genetic Healthcare Technologies.

Sterilization_statesNearly a year and a half ago, the GLR reported that North Carolina was one step closer to compensating the victims of its sterilization program. North Carolina’s eugenics program started with legislation in 1919 and was not officially abolished until 1977 (though the program’s sterilizations were performed between 1929 and 1974). The program victimized more than 7500 individuals and the number of victims surviving in 2010 was estimated at approximately 2950.
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Filed under Genomics & Society, Informed Consent

Looking Back at Myriad: A User’s Guide

MyriadThe Genomics Law Report has provided ample coverage throughout the litigation over Myriad Genetics’ BRCA1/2 patents. The saga had a rather lengthy procedural history, so a timeline of key landmarks with hyperlinks to GLR coverage as appropriate (in the “where” column) may be useful.

When Where Action Citation
1997 USPTO US Patent 5693473 issued to Myriad Genetics Inc.
March 2010 SDNY US Patent 5693473 invalidated AMP v. USPTO, 702 F.Supp.2d 181
July 2011 Fed Cir NY SDNY decision affirmed in part, reversed in part AMP v. USPTO, 653 F.3d 1329.
March 2012 SCOTUS Certiorari granted, Fed Cir NY judgment vacated, case remanded to Fed Cir NY AMP v. Myriad, 132 S.Ct. 1794
August 2012 FedCir NY Subsequent determination made (in light of Mayo v. Prometheus) AMP v. USPTO, 689 F.3d 1303
November 2012 SCOTUS Certiorari granted AMP v. Myriad, 133 S.Ct. 694
April 2013 SCOTUS Heard oral arguments
June 2013 SCOTUS Fed Cir decision affirmed in part, reversed in part AMP v. Myriad, 569 US —


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Filed under Badges, Genomics & Medicine, Legal & Regulatory, Myriad Gene Patent Litigation, Patent Litigation

DNA Fingerprinting as Routine Arrest Booking Procedure Upheld as Anticipated

1037193_dna_fingerprint_5

Jennifer K. Wagner, J.D., Ph.D., is a solo-practicing attorney in State College, PA and a research associate at the University of Pennsylvania’s Center for the Integration of Genetic Healthcare Technologies.

Oral arguments in Maryland v. King were held on February 26, 2013, as reported previously here on GLR. Following oral arguments, I stated, “If forced to predict, I would anticipate a split decision that uses a broad definition of ‘identification’ and upholds this ‘fingerprint for the 21st Century;’ however, I haven’t the foggiest as to whether a biometric identification exception will be created or whether a balancing test will be applied to reach that decision.
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Filed under Genomics & Society, Privacy

EEOC Files and Settles Its First GINA-based Employment Discrimination Lawsuit on May 7, 2013

Stethoscope & Laptop Jennifer K. Wagner, J.D., Ph.D., is a solo-practicing attorney in State College, PA and a research associate at the University of Pennsylvania’s Center for the Integration of Genetic Healthcare Technologies.

The Equal Employment Opportunity Commission (EEOC) issued a statement that it had filed a lawsuit against Fabricut, Inc. on May 7, 2013 in the U.S. District Court for the Northern District of Oklahoma, making it the first lawsuit brought by the agency to enforce genetic nondiscrimination rights afforded by Title II of the Genetic Information Nondiscrimination Act of 2008 (GINA). A consent decree was filed concurrently, thereby settling the lawsuit on the same day.
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Filed under General Interest, Genetic Testing/Screening, GINA, Legal & Regulatory

All Eyes on Maryland v. King: Recapping the Supreme Court Oral Argument

1037193_dna_fingerprint_5Seating was in short supply to hear oral arguments before the Supreme Court in what J. Alito referred to as “the most important criminal procedural case that this court has heard in decades,” Maryland v. King. Eager spectators –including this contributor for the Genomics Law Report – lined up along the marble steps of the Supreme Court building and waited amidst biting winter temperatures in excess of four hours before being allowed inside. [I thought to myself, “if I can brave the cold for football, I can brave the cold to see our nation’s highest court in action.”] The second of two cases scheduled for the morning of February 26, 2013, oral arguments for Maryland v. King were already underway when the fortunate final spectators were ushered inside. Katherine Winfree and Michael Dreeben argued for the Petitioners (the State of Maryland) and Kannon Shanmugam argued on behalf of the Respondent (Alonzo King).

The Genomics Law Report has covered the brewing constitutional controversy of DNA fingerprinting upon arrest previously, as U.S. v. Mitchell tentatively settled the matter in the 3rd Circuit, as the 9th Circuit continued to wrestle with Haskell v. Harris, and as various state courts, including Minnesota and Colorado [pdf], faced similar questions.

Background on Maryland v. King.  Alonzo Jay King, Jr. was arrested in 2009 and charged with first- and second-degree assault. As part of his initial arrest, King submitted to DNA fingerprinting collected by law enforcement under the Maryland DNA Collection Act. More than half the states [pdf] have statutes similar to Maryland’s, and there is also a similar federal statute (the DNA Fingerprint Act of 2005 [pdf]). King admitted to his involvement and was ultimately convicted of second-degree assault, a misdemeanor and an offense not qualifying on its own for DNA collection upon arrest under Maryland’s law.


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Filed under Biobanking, General Interest, Genomic Policymaking, Genomics & Society, Industry News, Legal & Regulatory, Pending Litigation, Privacy

ENCODE, CODIS, and the Urgent Need to Focus on what is Scientifically and Legally Relevant to the DNA Fingerprinting Debate

Sara Huston Katsanis, MS is an Associate in Research at the Institute for Genome Sciences & Policy at Duke University.

On September 5, 2012, a coordinated release of 30 articles in Nature, Cell, Science, Genome Research, Genome Biology and other journals published the long-awaited findings of The Encylopedia of DNA Elements (ENCODE) Consortium. The press coverage of ENCODE data is deafening at this point, and ENCODE’s relevance to GLR readers may not be immediately apparent.

Across the U.S., numerous groups are challenging the integration of CODIS profiles (sometimes called “DNA Fingerprints”) into the routine booking procedures upon arrest for certain crimes (depending on the state), placing genetic profiling among other standard procedures such as fingerprinting and mug shot photographs. The GLR has covered these legal challenges previously (including here, here, and here).
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Filed under Biobanking, Bioinformatics/IT, General Interest, Genomic Policymaking, Genomics & Society, Legal & Regulatory, Pending Litigation, Privacy