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Joshua SharfsteinAssociate Dean for Public Health Practice and Training, Joshua Sharfstein, published an article in yesterday’s Politico concerning regulations in the FDA that prevent over-the-counter medications from being updated based on new science and research. The article shares his long-held beliefs on FDA reforms as Congress considers legislation that could result in bi-partisan supported changes. As a former Principal Deputy Commissioner of the FDA, Sharfstein is very familiar with the regulations.

In terms of over-the-counter drugs, some of Sharfstein’s hopes for reform stem from learning that several Baltimore toddlers died from the toxic effects of over-the-counter cough and cold medications in 2006. Upon further research, Sharfstein learned that there is no scientific proof that these cold medicines are effective in young children and are more commonly associated with dozens of deaths and thousands of injuries across the country. 10 years ago Sharfstein organized a petition to the FDA for a change to children’s cold and cough medication, however, the FDA still has not acted because it lacks the tools to protect consumers from updates or new research with over-the-counter drugs as it does with prescription medications.

While explaining the weakness in the current FDA regulations, Sharfstein goes on to propose two reforms that would help protect consumers, as well as assist the FDA and manufacturers in developing new over-the-counter products and updating older products thanks to newer scientific developments.

The full article can be accessed online via Politico.

To me, the FDA has always seemed like a large, intimidating and confusing organization. I always assumed it was because I got lost in the science of the administration. Turns out, I’m not the only one to struggle with the FDA.

Last week, senior faculty from the Bloomberg School of Public Health, Harvard Medical School/Brigham and Women’s Hospital, Yale Medical School and Yale Law School, published in JAMA and the Bloomberg School’s website a Blueprint for Transparency that gives 18 recommendations in five principal areas to the FDA in an effort to be more transparent.

Each of the five areas push towards helping manufacturers and researchers make more progress by asking for more information on why decisions were made and where applications for approval are in the process. In addition, all 18 recommendations would not require new legislation from Congress and respects trade secret legal protections.

For the summary of the recommendations, check out the Bloomberg School’s press release; or delve into the entire 40 page blueprint.