Alexander: Congress Must Hold FDA Accountable

Friday, January 3, 2014

U.S. Senator Lamar Alexander, the lead Republican on the Senate health committee, Friday said that he’ll push in 2014 for an oversight hearing of the Food and Drug Administration and monitor its activities to ensure proper implementation of his legislation to help prevent another meningitis outbreak in Tennessee, which became law on Nov. 27.

“We worked for a year to create legislation that would help prevent another meningitis outbreak like the one that killed 16 Tennesseans and made so many others sick,” Senator Alexander said. “Tennesseans deserve to know that the FDA and other regulators are properly implementing this new law, which makes clear who is on the flagpole to prevent another nightmare like the deadly meningitis outbreak of 2012.”

The Drug Quality and Security Act distinguishes between compounders engaged in the traditional pharmacy practice of making customized drugs for specific patient needs 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 FDA as “outsourcing facilities” and become subject to federal oversight like traditional drug manufacturers. Those who choose to remain traditional pharmacies will continue to be primarily regulated by State Boards of Pharmacy. 

The legislation is based on a proposal Senator Alexander introduced in the U.S. Senate, as well as an agreement he helped reach with the U.S. House of Representatives. It also includes provisions to track and trace the more than 4 billion prescriptions that are written every year to help ensure their safety, and provides patients with better information on compounded drugs, said officials.

In November of 2012, when the Senate Health, Education, Labor and Pensions Committee held its first hearing on the deadly meningitis outbreak, Senator Alexander called for a new model of oversight of sterile compounding pharmacies. Alexander and HELP Committee Chairman Tom Harkin (D-Iowa), House Energy and Commerce Chairman Fred Upton (R-Mich.) and Ranking Member Henry Waxman (D-Calif.) announced a legislative agreement and the bill was passed by the House on Sept. 28. The Drug Quality and Security Act cleared by both houses of Congress on Nov. 18, and the president signed it Nov. 27.


Morning Pointe Residents Meet Miss Muffett

Residents at The Lantern at Morning Pointe Alzheimer's Center of Excellence, Collegedale, made the acquaintance of Miss Muffett, a Shetland pony who came to fame for her roles in movies and commercials.   As part of the Meaningful Day program, the memory care community invites furry, four-legged friends to spend quality time with the residents.   The 17-year-old ... (click for more)

CHI Memorial Asks To Be Removed As Pokémon Go Location

Leaders at CHI Memorial are warning associates, guests, and the public not to use any of the health care system’s facilities to play Pokémon Go.   “Patient safety and privacy are our top priorities,” said Rhonda Poulson, senior vice president and chief nursing officer. “This game can cause unwanted distraction to those providing and receiving medical care in our hospitals ... (click for more)

Hixson Man Charged With Sending Threatening Emails To General Sessions Court Judge

A 30-year-old Hixson man has been charged with making threats to kill General Sessions Court Judge Lila Statom after police said they found evidence to tie him to recent threats against the judge. David Lee Graham, of 1730 Colorado St., is charged with retaliation against a judge. His bond was raised to $100,000. Detective Ric Whaley said he had been conducting an investigation ... (click for more)

Man Arrested For Confronting Southside Grocery Employee With Gun

Brandon Jamal Appleberry, 27, was arrested on Monday after an altercation with an employee at Southside Grocery on West 38 th Street, officers said. Marty Witt, 44, told police that the suspect confronted him with a gun in his hand. Officers said security video from the store clearly showed Appleberry arguing with several people outside while holding a gun. The defendant ... (click for more)

Lock Her Up? - And Response

It's concerning that the Republican Party elite attending the recent convention would indict, convict and jail a political opponent, when the FBI found no criminal intent to compromise national security and no other law violations were found. This "lock her up" mob mentality is third world, over-the-edge behavior that has no place in a country based on the rule-of-law, where ... (click for more)

Roy Exum: Our Double Travesties

Back when we were kids the old guys taught us how to throw a one-two punch. It’s pretty impressive if you do it right, which is to jab your left fist into the thug’s face and then, as though it was a symphony, complete the combination as you deliver a powerful right cross to the same nose. If the thug has a gun, it doesn’t work as well. But, boy, did our community ever get clobbered ... (click for more)