FDA plans to improve O-T-C Drug Process

Update 1-28-2015: Over-The-Counter Drug Monograph System—Past, Present, and Future; Public Hearing and The Future: Modernizing the OTC Drug Review

The Food & Drug Administration (FDA) will host comments from the public March 25th & 26th regarding any suggestions to improve/expedite the process of approving or changing the label warnings on over-the-counter (OTC) “monograph” drugs. Monograph here is defined as drugs which have a “non-proprietary” list of ingredients to formulate which are available to many manufacturers.

The FDA hopes to approve more competitive drugs and devices faster to offer better economic choices for consumers. And at the same time, if problems arise like the acetaminophen issue linked with liver toxicity, they look to implement label safety warnings faster.

Note: My concern is that they don’t get outside pressure and will give enough time to determine if there are safety issues before they approve a product that could have been teted a little more.

Source: WSJ, 2-22/23-2014, A3.

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