The autumn colors are reaching near peak in Washington, D.C. and election fever is at its apex. By the next writing of a Weekly Roundup, we will know a lot more about the future direction of the country and of healthcare with a new Congress and a new President, and as per yesterday’s posting, I think there is every indication of change in our sector on the order of first magnitude. In the meantime, here is a little bit of what happened this week that I think bears noting:
- FDA Issues Warning Letters to Bayer on Combination Aspirin Product – As noted earlier this week, the FDA issued Warning Letters to Bayer regarding the marketing of two aspirin products. Said the FDA, "[t]he products, which contain aspirin with either phytosterols or calcium, are unapproved new drugs that require an approved new drug application in order to be legally marketed. In addition to being labeled for use as a pain reliever, both products are labeled for use in reducing the risks of heart disease. Bayer Women’s is also labeled for use in "fighting" osteoporosis. Neither product has been approved by the FDA for such uses. These drug uses require a health care professional’s diagnosis and supervision, and therefore these products cannot be labeled for use by consumers and sold over-the-counter (OTC). " Still, the FDA action came too late for the House Committee on Energy and Commerce which said – “The FDA appears to have responded to our investigation with appropriate action against Bayer Aspirin with Heart Advantage,” said Stupak. “While we appreciate the warning letter being sent, the FDA should not rely solely on Congressional oversight to notify them of such concerns. We need an FDA that is proactive rather than reactive when it comes to protecting public health.” This is yet another example of the mindset on the Hill that the FDA is in a follow mode instead of leadership mode.
- FDA Statement on Release of Bisphenol A (BPA) Subcommittee Report - The FDA agrees that, due to the uncertainties raised in some studies relating to the potential effects of low dose exposure to bisphenol A, additional research would be valuable. The FDA is already moving forward with planned research to address the potential low dose effects of bisphenol A, and we will carefully evaluate the findings of these studies. Consumers should know that, based on all available evidence, the present consensus among regulatory agencies in the United States, Canada, Europe, and Japan is that current levels of exposure to BPA through food packaging do not pose an immediate health risk to the general population, including infants and babies. Almost immediately, independent groups criticized and disputed this statement on BPA safety and by Congressmen Dingell and Stupak.
- A Video from Morningstar on Healthcare Status in the Financial Crisis – I’ve been very interested to see how the healthcare sector holds up in the face of what is going on in the economy. Here is a view on that topic from Morningstar which has been added to the EyeonFDA YouTube channel Investment Vids Playlist: