Tag: Prescription Drugs

LONDON, UNITED KINGDOM- 1 APRIL 2015: A newspaper rack holding several international newspapers, such as The International New York Times, USA Today, Irish Times, Londra Sera and Corriere Della Sera.

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

Ameet Sarpatwari Leave a comment

By Ameet Sarpatwari, Beatrice 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 April. The selections feature topics ranging from the pre-market development times for innovative vaccines, to an assessment of FDA postmarketing requirements and commitments from 2009 to 2018, to an analysis of implementation challenges and potential effects of U.S. adoption of international reference pricing for prescription drugs. A full posting of abstracts/summaries of these articles may be found on our website.

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Large pile of amber prescription pill bottles

A Look at Florida’s Decade-Long Effort to Curb the Opioid Epidemic

Temple University Center for Public Health Law Research Leave a comment

By Jessica Lam and Megan Bershefsky

Over the years, Florida, an early hotspot in the opioid epidemic, has implemented a series of legal and regulatory responses that have been met with both success and continued challenges.

Since 2016 — about 25 years into an opioid crisis that began in the 1990s — more than half of the country has passed laws to limit either the number of days or the amount of opioids that can be prescribed. Florida is on the leading edge of both the epidemic and efforts to use law to combat its effects, passing its first laws before many other states.

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

The Promise and Pitfalls of Trump’s “Most Favored Nation” Approach to Drug Pricing

Vrushab Gowda Leave a comment

By Vrushab Gowda

On September 13th, President Trump issued an executive order aimed at addressing ballooning pharmaceutical expenditures.

The order seeks to apply a “most favored nation” scheme to prescription drug payments made through Medicare Parts B and D, which are currently on track to exceed $130 billion. Although ambitious in scope, the order’s ultimate impact remains to be seen.

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A male pharmacist is examining a drug from a pharmacy inventory.

How Policies Enacted During COVID-19 Might Reduce Future Drug Spending

Beatrice Brown Leave a comment

By Beatrice Brown

The COVID-19 pandemic has prompted several states to take steps to temporarily authorize therapeutic substitution of drugs experiencing sudden shortages, whether due to spikes in demand or supply chain disruptions.

Although these instances of replacing patients’ typical prescription drugs with different drugs intended to have the same therapeutic effects have been prompted by necessity, therapeutic substitution more generally might reduce drug spending in the United States.

In a recent piece in the BMJ, Jonathan Darrow, Jessica Chong, and Aaron Kesselheim explore using state laws to expand the authority of pharmacists to substitute clinically similar alternatives in order to help cut spending. Actions taken by states to temporarily allow therapeutic substitution can help them gain experience with this strategy and potentially lead to broader and more permanent drug substitution policies that could help decrease drug spending.

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Researcher works at a lab bench

New Study Provides Insights into Potential Regulatory Treatment of COVID-19 Drugs

Beatrice Brown Leave a comment

By Beatrice Brown

As the global pandemic continues, trials have been established to test whether existing drugs such as hydroxychloroquine could be repurposed to treat patients with COVID-19. There are also hopes that a novel drug will surface. But questions remain about when treatments and vaccines will become available.

There is currently great optimism that a treatment or vaccine will be developed quickly, but there is no assurance that such a vaccine or treatment will be highly effective or that normalcy will return in any particular timeframe. A recent study published in the Lancet ID by Jonathan J. Darrow, Mehdi Najafzadeh, Kristina Stefanini, and Aaron S. Kesselheim provides data that might help to temper enthusiasm with evidence.

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Overdose Update: Celebrity Edition

Temple University Center for Public Health Law Research 1 Comment

By Scott Burris

You’ve probably heard about the good news/bad news experience of Stephanie Bongiovi, daughter of rocker Jon Bon Jovi. A college student, she ODed on heroin, but help was summoned and she’s going to be fine. The (temporary) bad news for her (and longer term for others in her plight) is that she and a companion were arrested IN SPITE of a recent New York Good Samaritan 911 law passed explicitly to encourage people to call for help.

There are some technicalities and prerequisites, so if you want to see the law it’s available on LawAtlas. But if she or her companion sought help, and absent a hyper-technical reading of the statute (it literally does not protect a victim unable to seek help), the charges should never have been filed and should be dropped. The problem for the rest of us is that these laws only work if people at an OD scene know about them and trust them. High profile arrests like this are — and for once I think there might be some truth to this claim — sending a message not to seek help.

Meanwhile, Leo Beletsky, Jody Rich and Alex Walley have a fine little piece in JAMA that thoroughly catalogues the removable barriers to OD prevention. The table alone is worth thousands of words, which is nice because JAMA’s editors were pretty tight on the word limit despite the importance of the topic.