Alexander: Senate One Step Closer To Passing Compounding Agreement To Help Prevent Future Tragedies

Wednesday, November 13, 2013

Senator Lamar Alexander (R-Tn.), the senior Republican on the Senate health committee, on Tuesday praised the Senate’s vote, 97 to 1, to move forward on consideration of the legislative agreement he reached with House and Senate health committee leaders to make injections of compounded sterile drugs safer. The House passed the bill on Sept. 28.

Senator Alexander said, “The Senate should consider and pass this legislation immediately so we can help prevent another meningitis outbreak like the one that has killed 16 Tennesseans and made so many others so sick. The FDA commissioner has warned us that it’s a matter of when, not if, this will happen again if we don’t clarify oversight of compounders. Tonight’s vote is an important step toward doing just that.”

Last November, when the Senate Health, Education, Labor and Pensions (HELP) Committee held its first hearing on the deadly meningitis outbreak, Senator Alexander called for a new model of oversight of sterile compounding pharmacies. Today’s bill represents an agreement announced by Senaotr Alexander and HELP Committee Chairman Tom Harkin (D-Ia.), House Energy and Commerce Chairman Fred Upton (R-Mi.) and Ranking Member Henry Waxman (D-Ca.) to clarify current federal law regarding pharmacy compounding and resolves the patchwork of current federal regulation by applying a uniform standard nationwide.

The bill also includes legislation to track and trace the more than 4 billion prescriptions that are written in America every year to help ensure their safety. There is currently no system for tracking prescription drugs, which means consumers can receive drugs that are stolen, counterfeit, or ineffective.  The bill would create a new uniform framework for tracking drugs from the manufacturer to the pharmacy.

The bill is supported by the Tennessee Pharmacists’ Association, who have said: "We believe this compromise proposal offers an effective approach to address complex issues surrounding compounded medications by having the Food and Drug Administration (FDA) focus on entities that are compounding outside the scope of traditional pharmacy compounding while leaving traditional pharmacy compounding under the oversight of state boards of pharmacy."

The legislation distinguishes compounders engaged in traditional pharmacy practice from those making large volumes of compounded drugs without individual prescriptions. Compounders who wish to practice outside the scope of traditional pharmacy practice can register with the Food and Drug Administration as “outsourcing facilities,” subject to FDA oversight in much the same way as traditional manufacturers. Those who choose to remain traditional pharmacies will continue to be primarily regulated by State Boards of Pharmacy as they are in current law.

It also offers providers and patients better information about compounded drugs, by directing FDA to make a list of FDA-regulated outsourcing facilities available on FDA’s website, requiring detailed labeling on compounded drugs, and prohibiting false and misleading advertising.


Local Female-Based Entrepreneurial Group Announces 2nd Annual Symposium

The WE | women entrepreneur symposium (formerly named Women At The Top Symposium or W.A.T.T.S) will be held on Tuesday, Aug. 5, from 8:30 a.m.-12:30 p.m. at Stratton Hall. Honorary WE Chairperson Congressman Chuck Fleischmann invites all women entrepreneurs to a symposium featuring Sloane Scott, a.k.a. the “Digital Diva” of FLO Thinkery, as the keynote speaker, and a panel discussion. ... (click for more)

The Industrial Farmhouse Producing Customizable, Sustainable Wood Furniture In Southside Chattanooga

The Industrial Farmhouse is a newly formed Chattanooga venture that creates, designs, markets, and distributes a wide variety of original styles of hardwood furniture.  They have trademarked “made in Chattanooga” to highlight their love for the Scenic City.  From their newly renovated workspace off Broad Street in the Southside District, a crew of craftspeople use hardwoods ... (click for more)

Erlanger Health System Projecting $10.8 Million Profit - With Help From $19 Million In Federal Funds

Erlanger Health System is projecting a $10.8 million profit for the upcoming fiscal year - with the help of $19 million in federal funds from a pool for public hospitals. The $19 million received in time for the current budget helped avoid a sizable deficit. The hospital is hoping the federal funds will be coming on an annual basis. At the start of the last fiscal year, ... (click for more)

Election Officials Hit 2 Snafus; Early Voting Brisk

Election officials have encountered two snafus in the early voting process, but administrator Kerry Steelman said they won't happen again. Due to a heavier turnout than was expected, Republican ballots briefly ran out on Friday at the Northgate precinct. And it was discovered after 10 people had voted, that the Domestic Partnership Ordinance was not included on the Kings Point ... (click for more)

Vote To Retain Supreme Court Justices

On Aug. 7 or by voting early by Aug. 2, voters will choose to "retain" or "replace" Tennessee Supreme Court Justices Connie Clark, Sharon Lee and Gary Wade. If retained, they will serve for another eight years.  The retention election is a way to retain judges who make decisions based on the law and facts -or remove judges who are incompetent. Tennessee's Judicial Performance ... (click for more)

Roy Exum: Judge Philyaw Is The Best

Tomorrow morning there will be a special gathering at the Hamilton County Juvenile Court that will prove to our community that we have perhaps the most innovative juvenile judge in America. Shortly after Rob Philyaw was hand-picked by our Hamilton County Commissioners to fill the remainder of Suzanne Bailey’s term 15 months ago, he found that truancy was a big problem in our schools. ... (click for more)