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.


Chattanooga Chamber Presents Business Calendar For March 7-14

TU/10 Hixson Council Community Coffee 8:00 a.m. to 9:00 a.m. Hamilton Funeral Home: 4506 Hixson Pike Free event.   TU/10 Export Boot Camp 8:30 to 10:30 a.m. TN Small Business Development Center: 100 Cherokee Blvd. Seminar will provide the nuts and bolts of information needed to become a successful exporter. Topics will ... (click for more)

LAUNCH Announces $100 For 100 Campaign

            In 2015, LAUNCH anticipates reaching the milestone of 100 entrepreneurs that have successfully started businesses with the help of their Business Entrepreneurship Academy.             LAUNCH continues to empower entrepreneurs, many of whom have overcome ... (click for more)

County Under Winter Weather Advisory; Hamilton County Schools On 2-Hour Delay

Temperatures were mild on Wednesday, reaching 74 degrees, but they began dropping as the day went on - leading to a winter weather advisory. The advisory goes into effect at 4 a.m. on Thursday and is to continue until 4 p.m. The forecast is for freezing rain and sleet. Hamilton County Schools will be on a two-hour delay on Thursday . School officials said, "Based on the ... (click for more)

Grand Jury Indicts Mark Kaylor In Alleged Beating Case; He Resigns From Red Bank Police; His Attorney Asks For Trial

A Red Bank officer was indicted on Wednesday by the Hamilton County Grand Jury on charges related to an alleged assault against a detainee. At the same time, Red Bank Police Chief Tim Christol said he had accepted the resignation of Officer Mark Kaylor. The Hamilton County District Attorney General’s Office earlier said it had reviewed the Tennessee Bureau of Investigation ... (click for more)

Women Don't Ask For Rape, They Ask For Justice

The stereotypical irrationality that women typically lie about rape has brought an enormous amount of social stigma to this population. Many like to think that rape is not a huge issue in the United States, and that the media blows it out of proportion. The Federal Bureau of Investigation (FBI) reported that approximately 17.7 million females in America have been raped, with 108,612 ... (click for more)

Roy Exum: Father Kelly’s ‘Hallelujah’

Last April, in the special way that only some older men are lucky enough to possess, the childish imp came out in Father Ray Kelly. A parish priest in Oldcastle, Ireland, he was conducting wedding vows for a handsome couple when the 62-year-old decided to surprise them with a totally-unscripted rendition of Leonard Cohen’s beautiful song, “Hallelujah.” When he did, there soon ... (click for more)