Category: FDA in the 21st Century Conference

Live Blogging from FDA in the 21st Century Conference, Panel 3: Protecting the Public within Constitutional Limits

The Petrie-Flom Center Staff Leave a comment

[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).

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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 2: Preserving Public Trust and Demanding Accountability

mmeyer Leave a comment

By Michelle Meyer

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

First up is Mark Lange from Eli Lilly (who notes that he is here in his personal capacity only!), speaking about “Data Transparency and the Role of the FDA.”

He prefaces his talk by noting that when he refers to “data,” he means raw, patient-level data from clinical trials. Most calls for the transparency of such data, he says, reflect a common theme about lack of trust in the pharmaceutical industry. So we might wonder: why doesn’t the pharmaceutical industry simply accede to that request and make their data available?

Mark notes that industry has several concerns. One important one pertains to data exclusivity. In several (if not all) markets, data exclusivity rights are premised on keeping the relevant data confidential, and posting it publicly would be deemed a waiver of those rights. In addition, data exclusivity prevents generic competitors from free riding, and publishing data could allow them to circumvent the very point of data exclusivity.

Moving to privacy concerns, Mark notes that research subjects’ understanding is that their data will be used for particular purposes and shared with regulators, but not be publicly posted on the Internet for anyone to do with whatever they want. Relatedly, there is the potential for interpretation of public data to be biased; research results may be over-interpreted and analyses may be flawed or even erroneous. Competitors might look for fairly trivial flaws the the data and try to use them to their advantage rather than sincerely trying to advance scientific progress and transparency.

Mark suggests, however, the choice between privacy and transparency is a false one. A better alternative is available — namely, for objective, expert regulators such as the FDA to receive and vet data in ways that address both audiences and both sets of concerns. The FDA is in fact already experienced in doing this. For example, it determines whether research demonstrates that a drug is safe and effective for a particular use through its marketing application approval mechanism, and it determines the accuracy and adequacy of the portrayal of research results in product labeling and product advertisements. And late last year, it was given responsibility for overseeing clinicaltrials.gov, which includes results from all pre-specified primary and secondary outcomes measures from nearly all clinical trials either conducted in the U.S. or intended to be used in support of an application for marketing approval in the U.S. This new responsibility, Mark suggests, could be a powerful tool, depending on how the FDA uses it. For instance, the FDA could exercise authority to monitor and enforce the absence of required results and the inclusion of false or misleading results data.

In concluding, Mark stresses that, when faced with requests for public access to patient-level trial data, we should consider the important role of regulators as trusted intermediaries who can balance competing concerns. Read More

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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