Category: Petrie-Flom Center

Live Blogging from FDA in the 21st Century Conference, Keynote: Deborah Autor

The Petrie-Flom Center Staff Leave a comment

[Posted on behalf of Jeffrey Skopek, Academic Fellow, Petrie-Flom Center (with the same disclaimer about the off-the-cuff nature of live blogging)]

Deborah Autor, Deputy Commissioner for Global Regulatory Operations and Policy, U.S. Food and Drug Administration (for now – and soon headed off to Mylan), gave a keynote address exploring the ways in which the FDA’s mandate is increasingly difficult to achieve in an era of globalization.

In the first  part of the talk, she provided an overview of the FDA, discussing the extent to which FDA-regulated products infuse nearly every aspect of life.   For example, 20 cents of every consumer dollar spend in the US is on a good that is regulated by the FDA (for a total of over 2 trillion dollars).   Further, the FDA must achieve this monumental task at very lost cost to the public – just 8 dollars per person per year.

The second part of the talk identified various ways in which modernization (e.g., the speed of technology, communications, and commerce) and globalization (e.g., the complex global regulatory landscape) is making the FDA’s mandate more difficult.   Just as disease knows no borders, product safety and quality no longer know any borders.  For example, FDA regulated products originate from more than 150 countries, 130,000 importers, and 300, 000 foreign facilities.   And the number of FDA regulated shipments at over 300 ports has skyrocketed.  For example, 10-15% of food products are imported, 50% of medical devices are imported, and 40% of drugs are imported.  Further, the global supply chains are complex and hard to oversee, in part because the increased number of individuals, producers, and companies are geographically dispersed; and also because the new and hard to regulate distribution channel for products, such as the internet.

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Live Blogging from FDA in the 21st Century Conference, Panel 1: FDA in a Changing World

I. Glenn Cohen Leave a comment

[This is off-the-cuff live blogging, so apologies for any errors, typos, etc]

Panel 1: FDA in a Changing World: Lewis Grossman, Ted Ruger, Barbara Evans, moderated by Holly Fernandez Lynch

Lewis Grossman, FDA in the Age of the Empowered Consumer

Begins his analysis by comparing a hypothetical consumer in 1960 and today.

Consumer was passive. Today’s consumer is active, more unmediated choice, more direct citizen involvement.

Why the change? 1970 was the decade of advocacy, culminating in 1972 Patient’s Bill of Rights from AMA. Central them was informed consent and thus complete information from physician.

1998 saw disruption of WebMd and now even more disrupted by web search technology which is how most patients get there info.

Food: 1966, recipe standards. Relatively little variety and consumer choice. Very little info on  nutrition, “batman white bread.” Turning point was 1969 White House conference that led to more choice and more info.

Health clams as the portal where 1st Amendment law entered into FDA law. The image of the intelligent consumer who need not be shielded from information.

Changes in standard by which FDA decided if something was misleading. Until 2002 unsure if reasonable or gullible consumer standard. In 2002 for food FDA chose the reasonable consumer standard.

Liberal and conservatives got scrambled on these matters in interesting ways.

Also a revolution in advertising, leading to revolution of patient’s relationship to his or her drugs.

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Live Blogging from FDA in the 21st Century Conference – Peter Barton Hutt’s Plenary

Holly Fernandez Lynch Leave a comment

We’re well on our way into the Petrie-Flom Center’s Annual Conference, FDA in the 21st Century, and we’ll be live blogging the sessions today and tomorrow here at Bill of Health.

Today’s sessions opened with a fantastic plenary from Peter Barton Hutt, who’s had more than five decades of experience with Food and Drug Law, including 4 years as Chief Counsel to the FDA.

Peter addressed a wide variety of topics in his talk on “Historical Themes and Developments Over the Past 50 Years.”

1.    FDA Management

Peter discussed various management approaches utilized by different FDA commissioners over the years, from Commissioner Edwards in the 1970s who ran the agency like a management consultant, meeting with every Center every week, to Commissioner McClellan who viewed his post through the lens of an economist.  Different management styles have been needed as the agency has grown tremendously, from 6,500 employees in 1976 to a $4 billion appropriation and more than 12,000 employees today.  As a result of that growth, the Commissioner and Center directors necessarily know less and less about what the organization is doing.  This creates tremendous possibilities for inconsistencies, mistakes, and loss of control, and ultimately, policy is now made from the bottom-up.

2.    Rulemaking

Peter described the fundamental shift in FDA’s approach to rulemaking over its history.  Before 1970, the agency relied heavily on a combination of guidance and litigation, primarily as a result of the fact that the four general counsels in that role from 1906 to 1971 were all litigators, and viewed lawsuits as the appropriate way to develop government policy.  It became clear in the 1970s that this approach couldn’t work for everything, and as a result, the agency reinterpreted an obscure provision of the Act allowing it to issue regulations for “efficient enforcement” of the law to permit substantive rulemaking, rather than just procedural rules.   This allowed huge programs to be created administratively, from nutritional labeling to OTC drug review to FOIA regulations.  Equally important was FDA’s approach to developing lengthy explanatory preambles to its regulations.

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Petrie-Flom Interns’ Weekly Round-Up: 4/20-4/26

The Petrie-Flom Center Staff Leave a comment

By Hyeongsu Park and Kathy Wang

  • Harvard University announced on Wednesday that it would shut down its primate research center over the next two years. The facility has been cited for animal welfare violations, but the university said that it was closing the research center due to a tough economic climate.
  • After a federal judge recently ordered the Food and Drug Administration to make the morning-after pill available to women of all ages without a prescription, a New York Times article discusses a broader issue that follows: whether birth-control pills should require a doctor’s prescription. Various groups, gynecologists, and politicians are sharply divided on this issue. The author discusses procedural hurdles and safety issues around making the morning-after pills over-the-counter drugs.
  • Utah recently became the first state to explicitly permit general prisoners (not death-row inmates) to donate their organs if they die while incarcerated. The New York Times introduces discussions among various academic and health professionals regarding the law allowing prisoners to become organ donors.
  • After Colorado voters approved a measure in November legalizing small amounts of marijuana for recreational use, Colorado legislators will discuss taxes on marijuana and the plan to use the tax revenues this week. The legislators are considering excise and sales taxes on marijuana of up to 30 percent combined. The goal is to set taxes high enough to finance the administration of new laws, but not so high that customers are driven back to the black market.
  • A group of Texas optometrists is lobbying the State Legislature for more power to negotiate contracts with health insurance companies, and the measure they support could hit consumers’ wallets.
  • British antitrust authorities accused the pharmaceutical giant GlaxoSmithKline of paying three rivals to delay the introduction of a generic version of antidepressant drug.
  • A Pennsylvania judge on Tuesday threw out three of seven murder charges against Dr. Kermit Gosnell, who was charged with killing viable fetuses while performing abortions.

Call for Applications: Student Internship Program

The Petrie-Flom Center Staff Leave a comment
The Petrie-Flom Center for Health Law Policy,
Biotechnology, and Bioethics at Harvard Law School
 
Call for Applications
Student Internship Program

 

The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School is seeking student interns for the upcoming academic year beginning in September 2013.   Full-year availability is preferred, but single-term internships will be considered on an individual basis; please indicate your preference in your application materials. We are not currently accepting applications for Summer 2013, but may consider extension through Summer 2014 if there is mutual interest.

Who is eligible?

Harvard undergraduate and graduate students with an interest in the Center’s work are eligible to apply. More information about the Center is available here. The internship is open to students in all disciplines, but we particularly welcome applications from students studying health policy, philosophy, bioethics, law, medicine, business economics, and the sciences.  We are also interested in receiving applications from students interested in technology and communications, as we plan to substantially update and expand our Internet presence and social media strategy.

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Reminder – Petrie-Flom Student Fellowship Applications Due May 20

The Petrie-Flom Center Staff Leave a comment

[Note: This Student Fellowship program is different from the Petrie-Flom Center Academic Fellowship, applications for which will open again in the Fall.]

The Center and Student Fellowship.  The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics is an interdisciplinary research program at Harvard Law School dedicated to the scholarly research of important issues at the intersection of law and health policy, including issues of health care financing and market regulation, biotechnology and intellectual property, biomedical research, and bioethics. The Student Fellowship Program is designed to support student research in these areas.  For more information on our current fellows and their work, see our website. 

Eligibility. The student fellowship program is open to Harvard Law School students and students in other Harvard graduate programs who are committed to undertaking a significant research project during the year of their fellowship. 

Keep reading for additional information on fellowship requirements and applications…

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Upcoming Talk: Pharmaceutical Efficacy, The Illusory Legal Standard

The Petrie-Flom Center Staff Leave a comment

Jonathan Darrow, PFC Student Fellow and HLS SJD student, will be presenting his chapter – “Pharmaceutical Efficacy: The Illusory Legal Standard” – on Tuesday, April 23, at noon in Hauser 105, Harvard Law School, Cambridge.

If you’d like to review the chapter in advance, please be in touch with Jonathan directly: jon underscore darrow at yahoo dot com.