The Other Health Care Reforms – FDA Growing by Leaps and Bounds

When the term "health care reform" is uttered, the mind unfailingly goes to think of the current bills being debated here in Washington to change the way health care is delivered in this country, most notably H.R.3200.  But there are other reforms underway that have been seeing movement in recent days, indicating that the momentum of change that was promised by the Administration is in fact underway.

First off, in the food fights – John Dingell's bill H.R.2749, the Food Safety Enhancement Act passed the House last week and the word in the Washington Post is that the Senate version will be voted on in September.  This puts the FDA one step closer to having several new enforcement powers over the manufacture and process of food in the U.S.  It is a "farm to fork" bill in scope which will allow authority over how crops are raised, giving the agency the ability to quarantine regions and to set new standards in traceability.  The legislation also will increase inspection rates of food manufacturing facilities to either every year or every 3 years, depending on the agency's assessment of the risk involved.  The agency will be able to accredit laboratories that provide food testing, establish an importation verification program and will authorize the immediate cessation of distribution of foods that might be contaminated.  The bill will be underwritten by user fees charged to manufacturers.  The bill does not split the FDA into two.  

Also related to food, the FDA announced the issue of three draft guidances for industry:  one to reduce microbrial infections from tomatoes, one from leafy greens and one on melons.  

And on the drug front, last week the House Energy and Commerce Committee voted 47-11 to include an amendment to the health care reform package of H.R.3200 for the development of a regulatory pathway for follow-on-biologics that is reflective of both H.R. 1548 as well as provisions of the Senate Health, Education, Labor and Pensions (HELP) Committee, according to a press release from BIO.  

Lastly, earlier this summer, on June 22, President Obama signed the Family Smoking Prevention and Tobacco Control Act (I guess if you're not part of a family, you can still smoke), which will add sweeping new authorities, and therefore staff, to the FDA as the agency gets nearer to implementation.  That work will be funded by a tax on tobacco and the agency will oversee the marketing of tobacco products.  

Change, on many levels, is happening and by coincidence, the size of the FDA is growing with it, and broadening the scope of the agency's charge dramatically.  
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