The slate of new appointees to healthcare-related jobs in Washington is already making its mark, from Margaret Hamburg, the newly confirmed commissioner of the Food & Drug Administration, to the White House officials charged with midwifing President Barack Obama’s ambitious healthcare reform agenda.
First there’s Hamburg, who detailed her view of the federal watchdog agency’s role in ensuring the safety of the nation’s $2 trillion food, drug and medical products pipeline.
In an op-ed article in the New England Journal of Medicine, Hamburg and principal deputy commissioner Joshua Sharfstein identified the century-old agency’s “overriding purpose” in protecting the public health:
“To be healthy, people need access to a safe and nutritious food supply and to innovative, safe, and effective medical products. The FDA’s job is to support this access and, in doing so, to promote health, prevent illness, and prolong life.”
When it comes to medical devices, the new FDA leaders said they aim to strike a balance between getting products to market as quickly as possible, in order to help patients, and ensuring that the devices receive adequate scrutiny to minimize potential health risks:
“A public health approach recognizes that the potential good of a new medical product or policy must be balanced against the potential harm. Some benefits are not worth the risk; some risks are worth taking. Key considerations are the severity of the illness at issue, the availability of alternative treatments or preventive interventions, and the current state of knowledge about individual responses.
“The FDA must make difficult decisions in the absence of ideal information. For medical products, the FDA Amendments Act of 2007 strengthened the agency’s ability to place restrictions on the use of medications at the time of approval while requiring that additional safety data be gathered. These tools allow the FDA opportunities to change the regulatory oversight of products as they move from limited use in clinical trials to adoption in the medical system. The ability to detect and act on safety signals quickly can give an additional layer of confidence to support earlier approval of important medications.”
Perhaps to allay fears that the new regime will be unfriendly toward industry, Hamburg and Sharfstein write that they’ll take into account the views of all stakeholders private and public:
“As a public health agency, the FDA should always ask whether delays in approval or safety problems can be prevented — a mandate that requires extensive and creative engagement with regulated industries, patient and consumer groups, and others. The FDA should actively pursue opportunities to help advance science in the domains it regulates and address threats to the safety of medical products and food — even if those opportunities and threats lie outside the realm of the agency’s usual routines. We expect to collaborate with other federal agencies and outside partners to address problems that the agency cannot solve alone.”
“After word leaked that a North Carolina insurance company
was planning Web videos critical of President Barack Obama’s proposal for a public health insurance plan, the White House health reform czar had the company’s chief executive on the phone explaining himself.
“And not long after the phone call between Nancy-Ann DeParle and Bob Greczyn of BlueCross BlueShield of North Carolina, the company dropped its plans to post the anti-public-plan videos on the Web.”
The new man in charge of the White House budget office, Peter Orszag, is no retiring wallflower himself.
“We are going to get health care done this year,” Orszag told Bloomberg, adding that most major healthcare groups — including, in his view, Republicans in Congress and varied and various industry players — “are on the side of reform.”
That’s a tall order for a $2.5 trillion system that accounts for 17 percent of the economy, especially when you consider that the order include insuring most — if not all — of the 46 million people now lacking coverage.