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Category Archives: Petrie-Flom Center
Labeling GMO Food
Check out this recent Bloomberg piece from Cass Sunstein: Don’t Mandate Labeling for Gene-Altered Foods. He raises a number of arguments that came out during the Q&A following our recent conference panel on food regulation. Video should be posted soon!
Petrie-Flom Student Fellowship Applications Due in One Week!
[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…
Petrie-Flom Interns’ Weekly Round-Up: 5/4-5/10
[Ed. Note: This will be the last intern round-up of the academic year, to resume in the Fall. Thanks, Hyeongsu and Kathy!]
By Hyeongsu Park and Kathy Wang
- The Food and Drug Administration announced Friday that generic versions of the painkiller Opana ER can remain on the market.
- Judge Edward R. Korman of the United States District Court for the Eastern District of New York ordered last month that the most common morning-after emergency contraceptive pill be available to women and girls of all ages without a prescription. On Friday, Judge Korman denied the request by government lawyers to suspend his ruling while they appeal. In the process, the judge stepped up his criticism of the Obama administration, accusing it of putting politics ahead of science.
- Three Republican members of the Oversight and Investigations Subcommittee have opened an inquiry into the safety of an amphetaminelike stimulant called dimethylamylamine, or DMAA, in some popular workout and fat-burning products sold at GNC.
- Wrigley said on Wednesday that it was taking a new caffeinated gum off the market temporarily while the Food and Drug Administration investigated the safety of added caffeine.
- Health and Human Services Secretary Kathleen Sebelius has called on health industry companies and other organizations, seeking financial contributions to help promote the Affordable Care Act that takes full effect next year.
- President Obama stepped up the sales pitch on the Affordable Care Act on Friday, saying that he was “110 percent committed” to delivering its benefits on schedule, and that consumers should not be misled by critics spreading misinformation about the law.
- The California Supreme Court on Monday upheld the right of local governments to ban medical marijuana dispensaries.
PFC Student Intern Applications Due Soon!
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.
Upcoming Conference: Issues and Case Studies in Clinical Trial Data Sharing
Live Blogging FDA in the 21st Century Conference, Panel 9 – Addressing the Challenges of and Harnessing New Technologies
Last but not least! Our final conference panel focused on “Addressing the Challenges of and Harnessing New Technologies,” and was moderated by Fran Miller.
We heard first from Margaret Riley on “Twenty-First Century Technology with Twentieth Century Baggage: FDA Regulation of Regenerative Medicine.” Riley explained that regenerative medicine (i.e., the use of pluripotent stem cells) has the potential to cure disease, injury, and even remedy organ shortages. Of course, it is a hugely political issue and the debate is emotional, value-laden, and not necessarily logical. As a result, the legislation/regulation that results in this area may be far from ideal.
Focusing on FDA specifically, Riley explained that the agency’s approach to stem cell regulation is rooted in its regulation of gene therapy and tissue products, as initiated in the 1990s. FDA’s regulation of autologous stem cell therapies – in which a person’s own cells are removed, manipulated, and reintroduced – as a drug was recently upheld by the District Court of DC (US v. Regenerative Sciences, 878 F. Supp. 2d 248 (DDC 2012)), but is now on appeal to the DC Circuit. Riley is not sure what the outcome will be on appeal, but noted that getting BLA’s approved on a doctor-by-doctor basis will be very difficult and likely impossible. One possible outcome of FDA regulation is likely to be off-shoring and stem cell tourism; ironically, strict regulation may end up not protecting patients, who will end up going abroad.
Next up was Nathan Cortez, who asked “Is the FDA Equipped to Regulate Mobile Health Devices?”
Live Blogging FDA in the 21st Century Conference, Plenary 3: Susan Winckler, President and CEO of FDLI
[Posted on behalf of Holly Fernandez Lynch, Executive Director, Petrie-Flom Center (with the same disclaimer about the off-the-cuff nature of live blogging)]
For the last plenary session of the conference, we heard from Susan Winckler, President and CEO of the Food and Drug Law Institute, who discussed “Other Influencers of Food and Drug Law” – namely the media and Congress.
Susan began by contrasting media past and present – from newspapers, radios, and TV news, today the agency has to contend with the range of issues and challenges associated with social media. There has been a shift from dealing with a defined press corps focused (and expert) on FDA to a “media of the masses,” which requires some level of training and background on the agency’s mission and intricacies. The agency can now also speak directly to the public, and be more proactive, without the filter of reporters and news media editors.
Associated with this media shift, Susan identified several new realities and challenges:
- How to explain complex scientific and legal issues in 140 character tweets?
- How to speak with “one voice” despite the fact that every agency employee now has a media outlet?
- How to address the expectation that FDA make declarations in real time, giving immediate responses to new developments?
Susan then moved on to discuss the various ways in which congress engages with and influences the agency, beyond amending the FDCA:
Live Blogging from FDA in the 21st Century Conference, Panel 6: Regulatory Exclusivities and the Regulation of Generic Drugs and Biosimilars
[Posted on behalf of W. Nicholson Price II, Academic Fellow, The Petrie-Flom Center (with the disclaimer re: live blogging - see posts below)]
The first panel of today is on regulatory exclusivity and generic drugs, moderated by Ben Roin at the Petrie-Flom Center.
Leading off was Kate Greenwood, discussing orphan drug development and recycled molecules. She started off with Makena, known as 17-P, first approved in 1976 as Delalutin. In 1996 FDA withdrew its approval at the manufacturer’s request, as it hadn’t been marketing it. A few years later, a study showed that the molecule, 17-P, helped prevent premature birth. Compounding pharmacies started making it, and in 2006, CustoPharm filed a Citizen’s Petition asking whether the way was clear for a generic; FDA said yes, though the route might be challenging. But in May 2006, a different company filed for a NDA for this new use; it was approved as Makena in January 2007; the company (KV Pharmaceuticals) priced it at $30,000 for a course of treatment (vs. $300 for the compounded version, still available pre-approval). Responding to criticism, FDA stated that Makena’s reliance on government funding did not prevent Orphan Drug application. But a few months later, FDA stated that compounding pharmacies could still make 17-P for patients; KV declared bankruptcy and blamed FDA’s decision not to discretionarily enforce Orphan Drug exclusivity. KV has since sued FDA and HHS, and the case is pending.
Kate moved on to discuss ways to adjust the innovation/access balance, including shortening the exclusivity period, allowing limited competition, or capping or controlling drug prices. There are concerns, however, that after Makena payers won’t really allow any monopoly price period.
Next up was Kevin Outterson, talking about opacity of R&D information; all we see are the shadows of data. There are $250 billion of branded drug sales, with something like $200 billion in patent rents in the U.S. alone (twice that globally). Patent theory describes this as the engine behind development in drugs – but it’s not free; we pay in higher drug prices. We’re paying for R&D, not the pills themselves, which would be priced at the generics’ cost. There’s no industry that celebrates inefficiency the way drugs do, touting the $1.2 billion figure for drug development. Don’t blame patent law, though! They require up-front disclosure. But that doesn’t apply to clinical data, which is kept locked away, only accessible to FDA. This process, which society pays for, is anathema to the scientific process.
Live Blogging from FDA in the 21st Century Conference, Panel 4: Timing Is Everything
Another great conference session this afternoon: “Timing Is Everything: Balancing Access and Uncertainty.” This one was moderated by Jeff Skopek, with presentations by Shannon Gibson, Trudo Lemmens, and Efthimios Parasidis.
First, we heard from Gibson and Lemmens on “Overcoming ‘Premarket Syndrome,’” AKA the various problems associated with relying solely on premarket data for safety and efficacy determinations. These problems include the fact that industry studies have been shown to be more likely to be biased in favor of demonstrating a positive result, and premarket studies also cannot really demonstrate how a product will be used in clinical practice. Moreover, for niche market drugs (e.g., those for orphan indications or pharmacogenomics), which are becoming more and more popular, there are fewer patients available to serve as clinical trial subjects, thereby inherently limiting the data that may be generated prior to approval and increasing uncertainty around safety and effectiveness.
So what should we do? Develop an improved post-market research agenda, say Gibson and Lemmens, and explore “adaptive licensing,” by which they mean rendering regulatory decisions based on the entire body of evidence collected throughout a product’s life cycle. They argue that drug access decisions should not be binary, but instead, should be incremental and continually reassessed based on new data, including data that becomes available after a drug has been initially made available to patients. They closed by pointing out the importance of data transparency at all points in drug regulation.
Next, we heard from Efthimios Parasidis on “Innovative Regulating as a Public Health Imperative.” Parasidis focused on the ways in which FDA can leverage its existing post-market regulatory authorities granted under the Food and Drug Administration Amendments Act of 2007, including requiring post-market studies and imposing Risk Evaluation and Mitigation Strategy requirements (REMS).
Live Blogging from FDA in the 21st Century Conference, Panel 3: Protecting the Public within Constitutional Limits
[Posted on behalf of W. Nicholson Price II, Academic Fellow, The Petrie-Flom Center (with the disclaimer re: live blogging - see posts below)]
The third panel at the conference covered commercial speech protection and off-label drug promotion, in reaction to the Second Circuit’s December 12 case, United States v. Caronia. Caronia was promoting Xyrem, approved for narcolepsy, for off-label uses, which is prohibited by FDA. He was criminally charged and convicted, but the Second Circuit held this prohibition constitutionally suspect.
Leading off was Aaron Kesselheim. Aaron started off describing the FDA’s prohibition on off-label promotion. Off-label promotion prohibition is based on the requirement of substantial evidence for efficacy. There are some safe-harbors, like distributing papers, but generally off-label promotion is prohibited because promotion drives prescription patterns, and off-label promotion for unapproved uses can have significant negative consequences. FDA has negotiated many major settlements, totaling billions of dollars in recent years. In this context, the Caronia decision is troubling from a public health point of view, even if not particularly surprising given the history of commercial free speech doctrine.
Aaron described four ways forward for the FDA after Caronia. First, the government could rely more heavily on written materials as evidence, arguing that it is part of the label. Second, the government could change the prosecutorial language, using speech as evidence of an attempt to misbrand, rather than prosecuting for speech; this might not be enough to fix the problem. Third, the government could prosecute off-label promotion as false and misleading speech, but that requires hard case-by-case evaluations. Fourth, the government could better argue that the Central Hudson test for commercial free speech is met.
Next, Chris Robertson also took Caronia as a jumping-off point, noting that Caronia was actually convicted of conspiracy to introduce a misbranded drug into interstate commerce – though the Second Circuit held he was actually convicted for his speech. Caronia comes in the wake of robust First Amendment jurisprudence from the Supreme Court, including Citizens United, Sorrell, Stevens, Alvarez, and Fox v. FCC, and thus might be a harbinger of this reasoning spreading across the country. In addition, the reasoning of Caronia could potentially apply equally to drugs with no approved use, and thus undermine the entire FDCA (since what is defined as a drug is determined by label claims).
Live Blogging from FDA in the 21st Century Conference, Keynote: Deborah Autor
[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.
Live Blogging from FDA in the 21st Century Conference, Panel 1: FDA in a Changing World
[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.
Live Blogging from FDA in the 21st Century Conference – Peter Barton Hutt’s Plenary
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.
Petrie-Flom Interns’ Weekly Round-Up: 4/20-4/26
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 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.
Reminder – Petrie-Flom Student Fellowship Applications Due May 20
[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…
Upcoming Talk: Pharmaceutical Efficacy, The Illusory Legal Standard
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.
Reminder: Petrie-Flom Annual Conference
5/17: Issues and Case Studies in Clinical Trial Data Sharing – What Have We Learned?
