By Phebe Hong
The first death of a federal inmate from COVID-19 occurred on March 28, at a prison in Oakdale, Louisiana. The inmate had been incarcerated for 13 years for a nonviolent drug charge. At least four other infected inmates have died at the same institution.
The COVID-19 pandemic is wreaking havoc on prisons and jails, where proper social distancing is nearly impossible to maintain.
By Phebe Hong
Data is knowledge, and knowledge is power. Thanks to a recent court ruling, more medical data may soon be available to the public. A Southern District New York federal judge ruled this week that the FDA and NIH had been misinterpreting a law requiring clinical trial sponsors to release data. The ruling clarifies that reporting requirements – previously applied only to trials completed after 2017 – actually applies to trials completed since 2007. As a result, many pharmaceutical companies, biotechs, universities, and other institutions will have to provide previously unpublished data (or risk non-compliance).
The ruling of Seife v. HHS has been broadly summarized by STAT, Endpoint News, and Science Magazine. Here, we take a closer detailed look at the court’s legal opinion and reasoning:
By Phebe Hong
A city northwest of Atlanta is taking on Big Pharma. On February 6th, the city of Marietta filed a lawsuit in federal court in Atlanta against Mallinckrodt, a global specialty pharmaceutical company. The class action complaint alleges that Mallinckrodt is “unjustly enriched” by its “exorbitant and unconscionable prices” for Acthar, a therapeutic adrenocorticotropic hormone (ACTH) approved in 1952 and indicated for various disease conditions, most notably infantile spasms and multiple sclerosis relapse. Marietta brings the class action suit on behalf of itself and “[a]ll third-party payors and their beneficiaries and people without insurance” that have paid for Acthar in the past four years.
By Phebe Hong
The Department of Health and Human Services’ patent suit against Gilead made headlines earlier this month (as described here and here). The government seeks damages for Gilead’s alleged infringement of HHS patents covering PrEP drugs for HIV prevention. The suit could set novel precedent in the realm of drug patent litigation – after all, very rarely does the government assert a patent against a large pharmaceutical company.
By Phebe Hong
The mission of the Patient Access Network Foundation (PANF) is “[t]o help underinsured people with life-threatening, chronic and rare diseases get the medications and treatments they need by assisting with their out-of-pocket costs and advocating for improved access and affordability.” PANF proudly boasts that since 2004, it has “provided nearly 1 million underinsured patients with over $3 billion in financial assistance, through close to 70 disease-specific programs.”
Despite its altruistic mission statement, PANF recently found itself in hot water. On October 24th, PANF agreed to a $4 million settlement with the Department of Justice over allegations that the group paid kickbacks to Medicare patients purchasing specific medications. In parallel, another patient group called Good Days settled for $2 million with the DOJ over similar allegations.
By Phebe Hong
On October 7th, toward the end of his health care “bill-signing marathon,” Governor Gavin Newsom signed bill AB 824, making California the first state to ban pharmaceutical “pay-for-delay” deals. The new law prohibits pay-for-delay deals, which is the practice of pharmaceutical companies giving “anything of value” to generic manufacturers to keep lower-cost generic versions off the market. The measure allows civil suits to be brought against pharmaceutical companies using such payment agreements to maintain monopolies for their higher-cost brand-name drugs.
By Phebe Hong
It happens every year like clockwork: Apple releases a new iPhone, and then hordes of people rush to buy it, despite still owning perfectly functional older models. We’re willing to shell out hundreds of dollars for a few extra camera features and new colors. As a result, Apple profits. A similar phenomenon is occurring in the drug industry, but with less consumer choice and more dire consequences.
“Product hopping” in the drug industry occurs when a pharmaceutical manufacturer winds down production of an old drug formulation whose patent expiration date has passed or is approaching. The company then forces or persuades patients to switch prescriptions to the drug’s new – and newly patented – formulation. A successful “product hop” extends a pharmaceutical manufacturer’s monopoly and therefore its ability to charge high prices.
By Phebe Hong
Protective orders, confidentiality agreements, and sealed court files significantly impair public access to vitally important records. Recent news coverage highlighting two high-profile drug product liability cases are ongoing examples of how our court system prevents crucial public health information from reaching the public domain.
By Phebe Hong
Nine months have passed since the startling news broke in November 2018 that Chinese researcher He Jiankui had used CRISPR/Cas9 to genetically modify the embryos of twin girls. The controversial news spurred the scientific and regulatory community into action. In late August 2019, two influential organizations — one from the private sector and one from the public sector — independently released statements announcing their efforts to establish standards for the nascent field of gene editing.
First, the Alliance for Regenerative Medicine (ARM), the advocacy organization representing cell and gene therapy companies, released its “Therapeutic Developers’ Statement of Principles,” offering an industry perspective on the use of gene editing technologies. Shortly thereafter, the World Health Organization (WHO) announced its plans to build a new registry and governance framework to track and regulate human gene editing trials. The statements symbolize an initial step by both private and public organizations to build consensus around responsible stewardship principles to prevent future scientific and ethical transgressions. It remains to be seen how such statements and plans will be implemented and how they will influence the field of genome editing research going forward.