Ohio Health Lawyer & Attorney : Jayne Juvan : Benesch Friedlander Law Firm : Serving Columbus, Cleveland, Cincinnati, Toledo, Akron, Dayton, Parma, Youngstown, Canton, and Lorain OH

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If you have an employee who isn't performing, would you expand the scope of the employee's duties?Apparently, some of our lawmakers would.  

Last week, the House Subcommittee on Oversight and Investigations held a hearing to discuss the many deficiencies of the FDA's drug review process.  At the hearing, David Ross, a ten year employee of the agency, stated that the FDA manifests a "culture of approval to get a drug product on the market as soon as possible."  He further referenced a drug that made its way to market despite evidence of fraud, liver damage and death.  While the transcript of the hearing is not yet available, you can listen to the testimony by visiting the Subcommittee's web site.   

At the same time, another group of lawmakers introduced legislation that would provide the FDA with the authority to regulate tobacco.  Among other things, as reported by the Kaiser Family Foundation, the legislation would allow the FDA to regulate the "sale, distribution and promotion of tobacco products."  In a Los Angeles Times article, Representative Henry A. Waxman is quoted as saying, "This bill is long overdue, and this is the year, I believe, that regulation of tobacco by the Food and Drug Administration is going to become law."

As highlighted in the Subcommittee's hearings, many believe that the FDA has ineffectively regulated drugs and devices.  Can the FDA handle this new mandate of tobacco regulation if it gains the force of the law?