Category: Pharmaceuticals

TOMORROW: Patents without Patents: Regulatory Incentives for Innovation in the Drug Industry

The Petrie-Flom Center Staff Leave a comment

February 19, 2014 12:00 PM Wasserstein Hall 1015
1585 Massachusetts Ave., Cambridge

In the pharmaceutical industry, patents are the preeminent incentive for innovation in developing new drugs.  But patents aren’t the whole story; regulatory agencies also offer different forms of exclusivity—enforced by the agencies themselves—to encourage different forms of innovation in the industry.  This panel will discuss actual and potential roles for those rewards in the context of developing new drugs, new uses for old drugs, and new ways to make drugs, in both the United States and the European Union. Panelists include:

  • Benjamin N. Roin, Hieken Assistant Professor in Patent Law, Harvard Law School; Faculty Co-Director, the Petrie-Flom Center
  • W. Nicholson Price II, Academic Fellow, the Petrie-Flom Center
  • Timo Minssen, Associate Professor, University of Copenhagen Faculty of Law; Visiting Scholar, the Petrie-Flom Center
  • Moderator, Aaron Kesselheim, Assistant Professor of Medicine, Harvard Medical School; Director of the Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women’s Hospital

This event is free and open to the public. Lunch will be served. For questions, contact petrie-flom@law.harvard.edu or  617-495-2316.

 

More on drug quality: India

W. Nicholson Price Leave a comment

By Nicholson Price

The New York Times had a troubling piece this weekend about major problems in drug quality in India, where FDA Commissioner Margaret Hamburg is visiting to discuss safety issues. India makes 40% of the U.S.’s generic prescription and over-the-counter drugs.

Quality issues seem to be unfortunately common (though of course there are many top-quality manufacturers and plants as well).  Half of all the FDA’s drug-related warning letters last year were issued to Indian plants, and recently popular drugs (including Neurontin and Cipro) have been banned from the United States if they’re manufactured in India.  Part of the explanation is differing standards for different markets; manufacturing standards are higher for the U.S. than for India, but the same companies are doing the manufacturing, sometimes at the same plants. Problems aren’t just about quality control in the plants – there are also major concerns with fraud.  In a particularly harrowing situation, “One widely used antibiotic was found to contain no active ingredient after being randomly tested in a government lab. The test was kept secret for nearly a year while 100,000 useless pills continued to be dispensed.”

(If you’re interested in pharmaceutical counterfeiting and are in New England, there’s what promises to be a terrific conference on pharmaceutical counterfeiting at UNH School of Law in Concord, NH on February 19 and 20; details are here.) Read More

New paper on “Standardization, IPRs and Open Innovation in Synthetic Biology”

Timo Minssen Leave a comment

By Timo Minssen

I am pleased to announce that we have today published the following paper:

Minssen, Timo and Wested, Jakob Blak, Standardization, IPRs and Open Innovation in Synthetic Biology (February 14, 2014). Available at SSRN.

This brief book contribution stems from a presentation given at the 2013 conference “Innovation, Competition, Collaboration” at Bucerius Law School, Hamburg, Germany. It is currently under review by Edward Elgar.  A longer journal-version will follow.

Abstract: 

An effective and just sharing of resources for innovation needs a supportive infrastructure. One such infrastructure of both historic and contemporary significance is the development of standards. Considering recent developments within the software and ICT industries, it seems fair to assume that the process of standardization may also have significant impact on the development and adoption of Synthetic Biology (SB). Within SB different standardization efforts have been made, but few have assumed dominance or authority. Standardization efforts within SB may differ within various technical areas, and also the basic processes of standard creation can be divided into various categories. The different technical areas and processes for standardization differ in their speed, handling of interests and ability to dodge possible IPR concerns.

Out of this notion arises i.a. the following questions: How comparable is engineering in SB to more traditional fields of engineering?; What type of standards have emerged and what bearing have IPRs on these?; and, How applicable are the approaches adopted by the standards-setting organizations in the information and communication technology (ICT) to biological standards? These and further legal issues related to IP, regulation, standardization, competition law & open innovation require a careful consideration of new user-generated models and solutions.

Before this background, our paper seeks to describe IP and standardization aspects of SB in order to discuss them in the context of the “open innovation” discourse. We concentrate on describing the technology and identifying areas of particular relevance. Ultimately we also sketch out open questions and potential solutions requiring further research. However, due to the limitation of this paper we do not aim to create elaborated theories or to propose solutions in more detail. Rather this paper, which will be complemented by more extensive follow-up studies, provides a first overview on the complex questions that we are currently dealing with.

To achieve this modest goal, section 1 commences with a brief introduction to the fascinating science of SB and a description of recent technological advances and applications. This will lead us to section 2, in which we will address standard setting efforts in SB, as well as the relevance and governance of various IPRs for specific SB standards. This provides the basis for section 3, in which we debate problematic issues and summarize our conclusions.

Drug shortages continue: new report

W. Nicholson Price 1 Comment

By Nicholson Price

The GAO released a report yesterday on the continuing problem of drug shortages, which unfortunately seem like they’re becoming a permanent part of the U.S. healthcare system.  Hundreds of drugs have at least temporary shortages–456 in 2012. The majority of drugs facing shortages are sterile injectable drugs, including some cancer drugs which have become part of the standard of care and other staples like nitroglycerin and basic IV fluids.

Although the FDA has increased powers to deal with drug shortages under the Food and Drug Administration Safety and Innovation Act of 2012 (FDASIA), those powers are still quite limited.  Manufacturers are now generally required to report shortages in advance to the FDA (previously only some types of manufacturers were so required), and the FDA can try to help.  But the FDA cannot require manufacturers to make drugs if they choose not to, and can offer little in the way of incentives to encourage them to continue making drugs or to increase production.

The causes of drug shortages are complex, and include regulatory, technological, and economic aspects.  A 2013 paper by FDA officials identified manufacturing quality problems as the single biggest proximate cause of drug shortages, and I’ve argued elsewhere that these quality problems stem from a lack of innovation in drug manufacturing.  Though FDA will do what it can to try to decrease shortages, it seems to me that without addressing the root causes (poor quality and relatively uncontrolled drug manufacturing, in addition to challenging–and linked–economic dynamics), we’re likely to see drug shortages continuing for a long time.

2/19: Patents without Patents: Regulatory Incentives for Innovation in the Drug Industry

The Petrie-Flom Center Staff Leave a comment

February 19, 2014 12:00 PM Wasserstein Hall 1015
1585 Massachusetts Ave., Cambridge

In the pharmaceutical industry, patents are the preeminent incentive for innovation in developing new drugs.  But patents aren’t the whole story; regulatory agencies also offer different forms of exclusivity—enforced by the agencies themselves—to encourage different forms of innovation in the industry.  This panel will discuss actual and potential roles for those rewards in the context of developing new drugs, new uses for old drugs, and new ways to make drugs, in both the United States and the European Union. Panelists include:

  • Benjamin N. Roin, Hieken Assistant Professor in Patent Law, Harvard Law School; Faculty Co-Director, the Petrie-Flom Center
  • W. Nicholson Price II, Academic Fellow, the Petrie-Flom Center
  • Timo Minssen, Associate Professor, University of Copenhagen Faculty of Law; Visiting Scholar, the Petrie-Flom Center
  • Moderator, Aaron Kesselheim, Assistant Professor of Medicine, Harvard Medical School; Director of the Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women’s Hospital

This event is free and open to the public. Lunch will be served. For questions, contact petrie-flom@law.harvard.edu or  617-495-2316.

The bright side of antibiotic resistance

jurrutia Leave a comment

My parent’s generation grew up in fear of a nuclear apocalypse: the cold war was raging, team USA and team USSR were competing in a frightening arms race, and people were building bomb shelters in preparation for a nuclear end to the world. That’s like so 1950’s though; what’s hot now is the environmental apocalypse. We all know about rising water levels, and some doomsayers are even warning that enough methane is about to be released from the icecaps to cause the greatest mass extinction since the dinosaurs.

Me? I’m not too concerned about either of these scenarios, but it’s not because I’m much of an optimist. It’s because I’m convinced that bugs will kill most of us before we kill ourselves.

In 1928, Alexander Fleming discovered penicillin, and it was being mass produced by World War II. This means it has effectively been around for at least 70 years, and it still works against a broad range of bacteria. Superb; 70 years is a hefty amount of time–enough for billions of doses to have been administered–and we’re still going strong.

But bacteria don’t care. They’re (still) here, they’re (always) evolving, get used to it.

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Capitalizing on Fecal Transplants

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By Deborah Cho

Last summer, the FDA reversed its previous decision that required researchers to file INDs for fecal transplants to treat Clostridium difficile.  This decision came without much official explanation as to the reasoning behind the reversal, but can be understood as a result of the unusually high success rates of fecal transplants in treating the deadly infection and the impracticality of applying IND requirements to the procedure.  As the FDA guidance notes, however, the agency’s “exercise of discretion regarding the IND requirements” affects only the use of fecal transplant to treat C. difficile and does not apply to the treatment of other diseases or conditions.

Despite the peculiarity of this type of treatment, researchers and patients alike seem to have embraced it for its ability to cure more than just life-threatening infections that have few other viable options.  In fact, a physician in Seattle studied the effects of fecal transplants on inflammatory bowel disease.  And, as it goes with many drugs, there even seem to be clinics claiming to use fecal transplants to treat weight loss. 

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TOMORROW: Second Annual Health Law Year in P/Review

The Petrie-Flom Center Staff Leave a comment

Please join us for our second annual Health Law Year in P/Review event, co-sponsored by the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School and the New England Journal of Medicine. The conference will be held in Wasserstein Hall, Milstein East C at Harvard Law School on Friday, January 31, 2014, from 8:30am to 5:00pm.

This year we will welcome experts discussing major developments over the past year and what to watch out for in areas including the Affordable Care Act, medical malpractice, FDA regulatory policy, abortion, contraception, intellectual property in the life sciences industry, public health policy, and human subjects research.

The full agenda is available on our website. Speakers are:  Read More