Drugs

Drug Company Patent Violations Cost $40 Billion: Study

The American Economic Liberties Project and the Initiative for Medicines, Access, and Knowledge (I-MAK) say the “illegal and anticompetitive tactics used by the pharmaceutical industry to perpetuate monopolies — in the form of government-backed patents over brand drugs — and block competition from more affordable generic drugs” cost final payers $40.07 billion in 2019. “This implies an average cost of about $120 in 2019 for every American, solely because of antitrust violations by the pharmaceutical industry,” the two groups’ report says.

Economic Liberties and I-MAK identified 10 overlapping strategies used by the drug industry:

horizontal collusion through agreements to raise prices, restrict output, rig a bidding process, allocate market share, or impose high prices or low quality across an industry rather than competing;
pay-for-delay or reverse payment;
non-generics agreement;
patent abuse such as sham patent litigation or patent thicketing (creating a web of overlapping patents to exclude competition) to extend monopolies;
product hopping and patent evergreening;
sham citizen petitions;
sham Orange Book listings;
REMS abuse;
exclusionary rebates; and
acquisition of monopoly.

The two advocacy groups recommend:

prohibiting pay-for-delay agreements between branded and generic drug manufacturers;
reforming FDA regulations to prohibit drug manufacturers from listing device-only and REMS patents in the Orange Book;
reforming FDA procedures to treat generics as substitutable equivalents to minimally adjusted versions of branded drugs;
dramatically increasing funding and resources to antitrust enforcers to tackle the problem of repeated pharmaceutical antitrust violations;
restricting laws around drug patent eligibility to ensure that drug companies can’t use bad-faith patent strategies to perpetually extend monopolies without creating useful enhancements in existing drug products;
developing sophisticated systems to identify likely antitrust violations from public data and intervene before patients and payers are harmed;
increasing penalties for corporations and individuals engaging in antitrust violations to better deter such conduct; and
empowering the Justice Department and state attorneys general to recover damages on behalf of public health programs, such as by filing follow-on cases to private litigation.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome