Change Agent - Pharmaceutical Executive


Change Agent

Pharmaceutical Executive

DTC Promotion and New Media

In her enforcement speech, Hamburg cited an agency crack-down on fraudulent Internet promotion of products that supposedly would protect consumers from swine flu. This development, along with concerns about drug companies posting unbalanced ads on search engines, has prompted a broad initiative to clarify FDA rules for marketing medical products via Web sites and social media.

"FDA is very concerned about fraudulent claims," Hamburg says, adding that US marketers need to "maximize the educational benefits of talking to consumers about health conditions."

Hamburg also understands that some policymakers want to impose a DTC advertising moratorium on newly approved drugs and adopt curbs on drug advertising similar to other nations. Her response is to express curiosity about standards in other countries—including New Zealand, the only other OECD country where drug DTC is officially allowed —and to urge marketers to provide "a stronger educational component" in medicines advertising. Hamburg recognizes that there are many under-treated health problems and poor compliance with medication regimens that could benefit from sound communication by industry. But she also is concerned about consumers "getting accurate and constructive information about important medical conditions. There are opportunities currently being missed," she says.

These issues will be addressed in a broader effort to modernize the rules governing prescription drug promotion, as proposed in FDA's Strategic Plan for Risk Communication unveiled in September. Current rules reflect a time when drug marketing was focused on health professionals, and not consumers, and thus overburden patients with detailed labeling information and technical data that is confusing and often uninformative.

FDA is drafting several possible new approaches, including a one-document method that provides patients with useful written information at the pharmacy. Other priorities are to finalize guidance on presentation of risk information in medical product promotions, and to conclude the ongoing effort to revise the brief summary of drug prescribing information. The overall plan is to evaluate FDA regulation of drug advertising, labeling, and sponsor interactions with healthcare professionals, and weigh the need for new legislation or rule making.

Key Mission: Restoring FDA's Reputation

Improved public confidence in FDA is "mission critical" for Hamburg, mainly because she recognizes that this is essential to securing a steady level of funding and resources. One of her key roles, she acknowledges, is to be an advocate for FDA and its needs. Policymakers must understand the importance of FDA's mission—quite simply, there is no other government agency, academic entity or private organization that can "step in and backstop" for the agency.

"It's astounding to me that given our centrality to the health and well-being of all Americans, we have been under-appreciated and under-resourced for so many years," says Hamburg. Digging out of the agency's depleted funding state will take some time, she acknowledges. "There is no quick fix. It's not a one-time funding increase."

Meanwhile, new legislation continues to expand FDA responsibilities. Congress established a new program to regulate tobacco products, which Hamburg considers vitally important for protecting public health. Support to fund this new responsibility will come through a user fee program, but it remains unclear whether this will be sufficient to meet the needs. Similarly, new food safety legislation will require a major expansion in inspection of food production and imports that may not be fully covered by added revenues. In addition, a required two-year inspection schedule for manufacturers that export to the US would be totally unmanageable and would far exceed proposed fees to support this assignment—all of which Hamburg told Congress a few months ago.

This, in particular, is where FDA is on the hot seat over conflicts of interest. Expansion of user fees to support these and other FDA activities raises concerns about the agency's over-reliance on industry funds. And the issue is sure to resurface as FDA begins to negotiate the next round of the Prescription Drug User Fee Act (PDUFA), which is up for renewal in 2012.

Hamburg does not feel that user fees compromise the integrity of the FDA review process. She believes that it's appropriate for regulated companies to contribute a share, along with public funding through the appropriations process. "What matters to me is that our work is important, and it has to be recognized that our responsibilities outstrip the available resources," says the Commissioner.

So far, Hamburg has enjoyed strong support from the Obama administration, Congress, and FDA's many constituencies. But at some point there will be a food contamination crisis or a drug safety problem on her watch, accompanied by a wave of finger-pointing. Hamburg is anticipating such an event, and is working to manage it by leveraging the current goodwill. How?

"We need to explain who we are, what we do, and how we do it so well, given all the constraints."

A New Breed of Regulator: Advocate for Public Health

Like many past FDA commissioners, Peggy Hamburg trained to be a doctor and medical researcher. Born in 1955 to two prominent physicians, she grew up on the Stanford University campus and went to Harvard for college and medical school. Her father, David Hamburg, is a past president of the Institute of Medicine; her mother, Beatrix, was the first African-American woman to earn a medical degree from Yale University. Peggy finished her medical training at Cornell University Medical Center and Rockefeller University in New York. But in the 1980s she disappointed her professors by dropping neuroscience research to go to Washington to work on AIDS treatment policy, first in the HHS Office of Disease Prevention and Health Promotion, and then at the National Institute of Allergy and Infectious Disease at NIH.

The year 1990 marked a critical new path in Hamburg's career when she joined the New York public health department, where she was named commissioner after only a year. There, she learned the tools for successful engagement in a broader agenda rife with politics and the passion of interest groups—not to mention the complexities of coping with large organizations whose broad priorities are often hard to reconcile because they are rooted in social conflict. She recalls her years in New York city government as difficult and demanding due to severe budget constraints, the spread of the AIDS virus, and an emerging tuberculosis epidemic. Among other achievements, she instituted controversial needle-exchange programs, boosted childhood immunization, and established an innovative treatment plan to halt the spread of drug-resistant TB.

A sign of her impact was that she was one of the few officials kept on board when Republican Mayor Rudolph Giuliani took office in 1994. She was elected a member of the Institute of Medicine at that time—one of the youngest ever to earn that honor.

Hamburg returned to Washington in 1997 as assistant secretary for policy and evaluation at HHS during the Clinton administration, where she created a bioterrorism initiative and led planning for pandemic flu response. In 2001 she joined the Nuclear Threat Initiative, a non-profit organization focused on reducing the threat to public health and safety from chemical, biological and nuclear weapons.

Health Reform: Defining FDA's Role

The current healthcare reform issue that involves FDA most directly is the proposal to establish an approval pathway for follow-on biologics. FDA officials have testified that they have the capacity to establish testing and regulatory standards for such products and that they prefer some flexibility in how they evaluate these complex therapies. But it will be a challenge to steer these products through the regulatory process, suggesting approvals may not come as quickly as some in the industry might like.

Commissioner Hamburg also sees FDA playing a supportive role in reforming the nation's healthcare system to provide more quality care and to avoid waste and harm. "Clearly the work that we do affects the availability of critical medical products, which, down the road, affects costs to the health care system," she tells PE. FDA's new Safe Use initiative aims to reduce unnecessary, preventable medical illness and complications due to the misuse or inappropriate use of medications and medical devices. "And that will clearly have an impact on cost and reduce the burden of disease," says Hamburg.

There are expectations that increased funding of comparative effectiveness research could expand the amount of information considered. FDA is "one of many players that makes decisions about the ultimate use of medical products," she notes. Hamburg does anticipate more collaboration with the Centers for Medicare and Medicaid Services to facilitate reimbursement of newly approved medicines. But that is on the back burner until the current health reform debate concludes and an official CMS administrator comes on board, one of the more prominent administration health positions that has not been filled.


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