Bottle of Truvada pills sitting on a bathroom sink

United States v. Gilead: The Fight for PrEP

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.

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Illustration of a robber wearing a mask runs off with a bag of money

Patient Advocacy Groups – Pharma in Disguise?

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.

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Blister pack of pills, but instead of bills dollar bills are rolled up in the packaging

Legal Challenges to California’s Pay-for-Delay Ban

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.

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Illustration of a cartoon man jumping from one oversized blister pack of pills to another

Stopping the Pharmaceutical “Product Hop”

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.

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Illustration of a scientist editing a DNA strand

Establishing Standards for Gene Editing: Initial Steps from Private and Public Actors

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.

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