Hundred dollar bills rolled up in a pill bottle

AbbVie Wins First Round in Humira Antitrust Lawsuit

By Ryan Knox and Gregory Curfman

Since receiving FDA approval for Humira® (adalimumab) in 2002, AbbVie, the drug’s manufacturer, has filed hundreds of submissions to the U.S. Patent and Trademark Office for secondary patents – almost half of which were filed after 2014, just two years before the expiration of its core patent.

These patents were largely directed to methods of use and potential formulation changes, but they did not include claims that affect the clinical efficacy of the biologic, which is used in the treatment of rheumatoid arthritis, Crohn’s disease, and psoriasis, among other conditions. Instead, the purpose of the secondary patent filings was to assemble a thicket of patents, 132 in all, to prohibit competition from biosimilar companies.

And so far, the strategy has worked. AbbVie remains the sole U.S. manufacturer of the biologic, and has successfully defended its domain: in June 2020, a federal district court judge in Chicago dismissed an antitrust lawsuit against AbbVie.

Read More

a pill in place of a model globe

Issuing the Most Favored Nation Interim Final Rule Was a Mistake

By Abe Sutton

While the Most Favored Nation (MFN) Interim Final Rule (IFR) advances a well-calibrated policy to standardize pharmaceutical prices across developed nations, procedurally, its issuance was a mistake.

The Trump administration would have been wiser to issue a Notice of Proposed Rulemaking (NPRM) for two reasons: first, an NPRM would have circumvented some of the procedural vulnerabilities of the IFR. And second, had the Trump administration issued an NPRM, President-Elect Biden’s team would have faced significant pressure to finalize the policy.

In this post, I touch on what MFN is, examine why the interim final rule is legally vulnerable, explore why the Biden team likely would have adopted the policy had an NPRM been issued, and explain how industry should think about this situation.

Read More

Map of United States made up of pills.

Monthly Round-Up of What to Read on Pharma Law and Policy

By Ameet SarpatwariBeatrice Brown, Neeraj PatelandAaron S. Kesselheim

Each month, members of the Program On Regulation, Therapeutics, And Law (PORTAL) review the peer-reviewed medical literature to identify interesting empirical studies, policy analyses, and editorials on health law and policy issues.

Below are the citations for papers identified from the month of September. The selections feature topics ranging from commentaries on political pressures and questions of integrity facing the FDA, to a critique of the financial incentive structure for antibiotic development, to an estimation of how much NHS England would spend if it paid U.S. Medicare Part D prices. A full posting of abstracts/summaries of these articles may be found on our website.

Read More

a pill in place of a model globe

Monthly Round-Up of What to Read on Pharma Law and Policy

By Ameet SarpatwariBeatrice Brown, Neeraj Patel, and Aaron S. Kesselheim

Each month, members of the Program On Regulation, Therapeutics, And Law (PORTAL) review the peer-reviewed medical literature to identify interesting empirical studies, policy analyses, and editorials on health law and policy issues.

Below are the citations for papers identified from the month of August. The selections feature topics ranging from a commentary on the need for rigorous scientific evaluation of COVID-19 vaccine candidates in the face of political and economic pressures, to an evaluation of patients’ and pharmacists’ experiences with pill appearance changes, to an examination of the extent and cost of potentially inappropriate prescription drug prescriptions for older adults. A full posting of abstracts/summaries of these articles may be found on our website.

Read More

Large pile of amber prescription pill bottles

Monthly Round-Up of What to Read on Pharma Law and Policy

By Ameet SarpatwariBeatrice Brown, Neeraj Patel, and Aaron S. Kesselheim

Each month, members of the Program On Regulation, Therapeutics, And Law (PORTAL) go through recent, peer-reviewed medical literature to identify interesting empirical studies, policy analyses, and editorials on health law and policy issues.

Below are the citations for papers identified from the month of July. The selections feature topics ranging from an assessment of excess prescription drug spending associated with delayed generic competition, to an analysis of the differences between the use of advisories by drug regulatory bodies in various countries, to a commentary on the pitfalls of using SSR Health data for estimating net prescription drug spending. A full posting of abstracts/summaries of these articles may be found on our website.

Read More

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

To Cut Prescription Drug Spending, Stop Delays for Generic Competition

By Beatrice Brown and Benjamin Rome

Prescription drug spending in the U.S. remains high and continues to rise, accounting for about 20% of national health expenditures. While generic competition is crucial for reducing drug prices, brand-name drug manufacturers can utilize several strategies to delay such competition by increasing the length of market exclusivity for their drugs.

Although brand-name drugs only account for 18% of all prescriptions filled, they comprise 78% of total drug spending. By contrast, equally-effective, interchangeable generic drugs can offer discounts of up to 80% off their brand-name drug counterparts.

Generic competitors can only be introduced after brand-name drugs have completed their period of market exclusivity, which typically lasts 12-16 years and is largely determined by the patents covering the drug. Brand-name pharmaceutical manufacturers have strong financial incentives to prolong this market exclusivity period and delay entry of generic products.

Read More

Large pile of amber prescription pill bottles

Monthly Round-Up of What to Read on Pharma Law and Policy

By Ameet SarpatwariCharlie LeeFrazer Tessema, and Aaron S. Kesselheim

Each month, members of the Program On Regulation, Therapeutics, And Law (PORTAL) review the peer-reviewed medical literature to identify interesting empirical studies, policy analyses, and editorials on pharmaceutical law and policy.

Below are links to the papers identified from the month of May. The selections feature topics ranging from the association between clinical benefit of approved cancer drugs and their prices in the U.S. and Europe, to an assessment of how commercial health plans cover biosimilars relative to their reference products, to a commentary on how children should be included in clinical trials evaluating COVID-19 therapies. A full posting of abstracts/summaries of these articles can be found on our website.

Read More

Harvard X logo

New HarvardX Course on the FDA and Prescription Drugs

Interested in learning more about pharmaceutical policy? Curious about the role of the FDA in ensure safe and effective drugs reach the market? Wondering why drug prices are so high in the US? Readers of my prior posts may enjoy learning more about these topics!

Check out a free HarvardX online course, “The FDA and Prescription Drugs: Current Controversies in Context,” put together by Petrie-Flom Center affiliates Dr. Aaron Kesselheim, Dr. Ameet Sarpatwari, Dr. Jonathan Darrow, and many others, that is now open for enrollment. (Disclosure: I did not play any role in the development or making of the course, but I am serving as a teaching assistant/discussion moderator for the course). Read More

Close-up of a stethoscope on an American flag

Healthcare Already Taking Center Stage in 2020 Democratic Primary Race

With Massachusetts senator Elizabeth Warren (D-MA) announcing that she was forming a Presidential exploratory committee, I suppose that means the 2020 Democratic Primary is off to the races. Joining her are some lower profile candidates, including John Delaney (former MD congressman), Richard Ojeda (WV state senator and former congressional candidate), Tulsi Gabbard (HI congresswoman), Julian Castro (former secretary of HUD). And within the last week, senators Kirsten Gillibrand (D-NY) and Kamala Harris (D-CA) put their hats in the ring.

While many issues are likely to play prominent roles in this campaign — immigration, taxes, inequality, housing, universal pre-k, college affordability, environment/climate change — healthcare is likely to play an outsized role after Democrats found it to be a winning issue in 2018.  Read More

close up of human eye

The Luxturna Debate: Why Ethics Needs a Seat at the Drug Pricing Table

By Clio Sophia Koller

Jack Hogan can now ride his bike home at dusk after an afternoon of playing with his friends. Is that childhood rite-of-passage worth $850,000?

Recently, the Health Policy and Bioethics Consortium convened by Harvard Medical School’s Center for Bioethics and the Program on Regulation, Therapeutics, and Law (PORTAL) at Brigham and Women’s Hospital met to discuss the implications of Spark Therapeutics’ new gene therapy treatment—along with its staggering price tag.

Luxturna, a novel therapy approved by the FDA last year, treats a rare form of inherited blindness known as retinitis pigmentosa. The therapeutic agent targets the RPE65 gene, associated with the disorder, and is shown to improve vision in a population with progressive vision-loss and an inability to see in dim light. Read More