About the AuthorMy name is Mark Senak. I’m a lawyer and I work at the international communications firm FleishmanHillard in New York. For the past several years, I have been consulting with pharmaceutical and biologic companies that are engaged in the process of bringing new drugs to market. I have also worked extensively with an array of medical societies and patient organizations providing strategic communications counsel and media training.
My ProfileI am an authority on regulatory aspects of communications and medical products, with particular emphasis on pre-approval communications; strategist to help pharma and biotech companies prepare best case for advisory committee approval; and counselor in issues and crisis management. I am a frequent speaker on various aspects of same - drug development, promotion, reimbursement and new media in a highly regulated environment. Author of books, newspaper and magazine pieces related to drug marketing and promotion as well as HIV specialty pieces. And of course... blogger!
About This Blog
Eye on FDA is published by Mark Senak of FleishmanHillard’s New York office. The thoughts and ideas in this blog and postings are strictly my own and are not screened by my employer. Everything posted on this blog is my personal opinion and does not necessarily represent the views of FleishmanHillard or its clients.
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Late last week the Senate finally voted along with the House to give authority to the FDA to regulate tobacco – a move specifically required when the silly Supreme Court said that the FDA did not have such authority. That was in spite of the fact that cigarettes are nothing more than a device to deliver a drug – nicotine – into the body. Other than that, there is no purpose to them. But the Supremes have made major mistakes before (the Korematsu case where they decided it was ok with the Constitution that Japanese-Americans be sent to concentration camps; the Dred Scott decision which said the same about slavery) and they will in the future. In any case, the damage is now undone and the President will sign the bill into law.
It took 40 years after the Surgeon General warned of the uses of tobacco for the Congress to act. No grass grows under their feet.
What does it mean? it establishes the ability of the agency to regulate the advertising and marketing of the product. They won't get to call light cigarettes "light" anymore. They will charge manufacturers a tax that will be passed on the consumer to hire staff at the FDA to do so. Then there will be a challenge by industry on the free speech aspects of all of that. The Supremes will get another crack at getting it right.
But actually, theone thing the FDA won't have the power to do is to pull tobacco from the market entirely. That is ironic isn't it?
I mean, what if a drug were on the market that had the same set of adverse events as tobacco – or the same risk/benefit ratio? Man, the Congress would be hopping mad – the FDA Commissioner would be hauled in for major hearings and disgraced on the Hill. People would call for a new Commissioner. An FDA whistle-blower would come in with something to say about it all and link up with a particularly loud member of Congress. An aspiring FDA Commissioner would write an editorial in a major medical journal. Newspapers all over would create hysterical headlines calling for action. The nation would deplore the inability of the FDA to move to get the drug off the market.
The drug is called nicotine. The drug has no benefit whatsoever. It has only risk. Congress should do the math.