In the October 22 edition of The New Yorker, Michael Specter wrote a fascinating article about the growing and exciting science of the human microbiome, the ecosystem of ten thousand or so bacterial species that call each of our bodies home. The hype around this particular field of scientific and medical inquiry is intense: Specter quotes David Relman of Stanford Medical school as saying that right now we are in the “beautiful, euphoric, heady early period” of the field, and notes that each week seems to bring additional symposia, publications, and grants for new research. All of this is for good reason. Promising studies have indicated that microbial therapy (the intentional introduction of certain bacteria into the body) can be an effective treatment for some diseases, while other researchers have suggested that a variety of modern diseases (like asthma, inflammatory-bowel disease, and some allergies) may be tied to changes in the human bacterial ecosystem. In some ways, this isn’t news: as Dr. Douglas Archer noted in an FDA advisory committee meeting on probiotics over a decade ago, using food with live cultures to treat disease is a longstanding practice dating at least as far back as 76 BC, when the Roman historian Plinio advocated using fermented milk to treat GI infections. Read More
Category: Patrick O’Leary
Regulating Compounding Pharmacies: Why An Increased FDA Role Shouldn’t Be Our Default Option
A friend and I were having a conversation about health policy the other day when he observed that drug regulators like FDA face an impossible task in terms of public expectations: as consumers, we expect the drugs we take to be 100% safe, 100% of the time. Of course, no regulator, no matter how powerful or well funded, could deliver on that expectation, and the reality is that FDA operates under a variety of limitations, both fiscal and legal.
The current deadly meningitis outbreak linked to contaminated injections made by a Massachusetts compounding pharmacy shocks us and upsets our expectation that the drugs we take to get better will not, at the very least, cause us harm. Responding reflexively to this crisis, many in the media and in Washington have already started to call for greater federal oversight. This is a natural impulse, but one that merits cool-headed consideration. FDA is an agency that already has a broad statutory mandate and limited resources. Enforcement resources are slim enough that the agency’s response to an HHS report this month finding rampant violation of dietary supplement-labeling laws was simply to say that the agency would “address the recommendations as its resources and priorities allow.” Before we add still further to FDA’s crowded plate at a time when it is already facing a potential budget crisis (and it is worth noting that according to at least one former FDA chief counsel and congressional testimony by agency officials, FDA already possesses the authority to regulate pharmacies like the one involved in the outbreak and historically has done so), it is worth asking whether FDA enforcement is the only or best solution to the problem.
The Fallacy of Fearing “Industrialized” Medicine
Looking back over last month’s health-related news, two articles published on The Atlantic’s website stand out to illustrate a tension that has received a great deal of focus in Medicare reform circles, and that seems to be a political sticking point for many otherwise promising cost-reduction strategies. In his September 10th article The Fallacy of Treating Health Care as an Industry, Professor Gunderman of Indiana University criticizes a recent Institute of Medicine (“IOM”) report suggesting that our medical system could be providing better care at lower cost if it could only learn a few lessons from other industries. Professor Gunderman’s critique invokes the specter of mechanical medicine: an “industrial assembly line approach to medicine” where the pursuit of efficient care utterly eclipses the human element, the “communication and relationships” that make the practice of medicine more than just an industry. Similar arguments can be and have been deployed against any resource-sensitive reform of medical practice, as the “death panels” debate from several years ago well illustrates.
While these kinds of human-relationship based critiques of efforts to make medical care more efficient may be relevant in the context of more extreme proposals of medical rationing, they are misguided as applied to recommendations like those made in the IOM report. Read More
Is FDA’s 2013 Budget At Risk?
Back in February, President Obama’s FY 2013 budget authorized $4.5 billion for the Food and Drug Administration (FDA), about $2 billion of which was to come from user fees, the fees paid by regulated industry under a variety of schemes including the Prescription Drug User Fee Act (PDUFA), the Medical Device User Fee Act (MDUFA) and newly-created programs for generic drugs and biosimilars. As of today, FDA’s ability to collect and use these fees is in question, endangering vital agency activities including drug and device premarket review.
The threat to FDA user fees crystallized on September 14, when the Office of Management and Budget released its Report Pursuant to the Sequestration Transparency Act of 2012, explaining what may happen if Congress fails to reach an accord on the federal budget as required by the Budget Control Act of 2011 (BCA). Such a failure would trigger sequestration resulting in an 8.2% reduction in non-exempt, non-defense discretionary funding. On pages 79-80, the report indicates that $3.873 billion of FDA’s budget for 2013 is considered eligible for sequestration. According to analysis by the Alliance For a Stronger FDA, this indicates that major user fee programs have been included as sequestration-eligible funds. According to the OMB report, the FDA budget would be reduced under sequestration by around $318 million.
Introducing Our Student Bloggers
We’ll have several Harvard graduate students blogging with us this academic year, including the 2012-13 cohort of Petrie-Flom Center student fellows.