House Passes Alexander Compounding Agreement

Sunday, September 29, 2013

The  House of Representatives has passed a legislative agreement Senator Lamar Alexanderreached with House and Senate health committee leaders to clarify oversight of the nation’s compounding facilities.

 

Senator Alexander said: “This is a big step toward preventing another nightmare for Tennesseans like last year’s tragic meningitis outbreak, which the FDA commissioner tells us will happen again if we don’t fix the uncertainty over who’s in charge of compounding facilities. The House has passed our agreement to make it clear exactly who is in charge of overseeing each compounding facility, so there will be no questions about who’s on the flagpole. I urge the Senate to act swiftly and send this bill to the president to sign.”

 

Today’s bill represented an agreement by Alexander and Senate Health, Education, Labor and Pensions (HELP) Committee Chairman Tom Harkin (D-Iowa), House Energy and Commerce Chairman Fred Upton (R-Mich.) and Ranking Member Henry Waxman (D-Calif.). The bill clarifies current federal law regarding pharmacy compounding and resolves the patchwork of current federal regulation by applying a uniform standard nationwide.

 

Last November, when the Senate HELP Committee held its first hearing on the deadly meningitis outbreak, Alexander called for a new model of oversight of sterile compounding pharmacies.

One year ago, the meningitis outbreak caused by contaminated compounded drugs from the New England Compounding Center alerted the nation that providers and patients need sources of safe compounded drugs.  Following the outbreak, a bipartisan group of HELP Committee Senators— led by Chairman Harkin, Ranking Member Alexander, Sen. Pat Roberts (R-Kan.), and Sen. Al Franken (D-Minn.)—developed legislation to help ensure that quality compounded drugs are available to patients who need them.

Among other highlights, 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 as outsourcing facilities, but those who choose to remain traditional pharmacies will continue to be primarily regulated by State Boards of Pharmacy as they are in current law.
  • Defines the Food and Drug Administration’s (FDA’s) role in oversight of outsourcing facilities.  Outsourcing facilities would be subject to FDA oversight in much the same way as traditional manufacturers.  FDA will know who these outsourcers are and what they are making, receive adverse event reports about compounded drugs, and have the authority and resources to conduct risk-based inspections.  The legislation will give providers and patients the option of purchasing products from outsourcing facilities that comply with FDA quality standards.
  • Offers providers and patients better information about compounded drugs.  The legislation directs FDA to make a list of FDA-regulated outsourcing facilities available on FDA’s website, requires detailed labeling on compounded drugs, and prohibits false and misleading advertising.
  • Clarifies current federal law regarding pharmacy compounding.  The legislation strikes unconstitutional provisions in current law, resolving the patchwork of current federal regulation and applying a uniform standard nationwide.

 

The bill is supported by the Tennessee Pharmacists Association, who stated: "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 bill also includes legislation based upon a bill passed unanimously by the Senate health committee that improves patient safety by replacing today’s patchwork of state pharmaceutical drug tracing laws with a strong, uniform standard that would ultimately result in electronic, interoperable unit level drug tracing for the entire country.  The last comprehensive effort to establish safeguards for the drug distribution supply chain was twenty-five years ago.  This bipartisan, bicameral draft is the result of several years of work to address the growing problem of pharmaceutical theft, counterfeiting, and diversion.  

Among other highlights, the legislation:

  • Develops a workable pathway to unit-level tracing in a decade. Over the course of seven years, the major sectors of the pharmaceutical supply chain, such as manufacturers, repackagers, wholesale distributors, and dispensers will all be passing and holding onto key information about each drug’s distribution history.  Within ten years, supply chain stakeholders will participate in electronic, interoperable drug tracing.
  • Strengthens licensure requirements for wholesale distributors and third-party logistics providers.  Wholesale distributors will have higher standards for their licenses nationwide, and third-party logistics providers will be recognized for the first time as a part of the drug supply chain. FDA will also keep a database of wholesalers that will be available to the public through the FDA’s website, allowing consumers and members of the drug supply chain to identify appropriately licensed wholesalers.
  • Establishes nationwide drug serial numbers.  Four years after the date of enactment, manufacturers will serialize drugs in a consistent way across the industry.  This will allow for efficient tracing to respond to recalls and notices of theft and counterfeiting.   

Northside Neighborhood House Receives Gift From Food Lion

Northside Neighborhood House has received $1,000 from the Food Lion Feeds Charitable Foundation to help feed and provide education to local residents. Northside Neighborhood House will use the gift for its Healthy Families Program, which offers cooking classes and family dinner nights.  “The NNH is so grateful for this support from Food Lion Feeds Charitable Foundation,” ... (click for more)

2nd Annual IgniteRed Event: Thank You, Chattanooga

Southern Surgical Arts sponsored the 2nd annual IgniteRed event last Friday in conjunction with the American Heart Association’s National Wear Red Day. During this informal evening of entertainment and networking, more than 200 of Chattanooga’s women gathered in support of a common goal: to raise awareness about heart disease. "It’s a topic of vital importance to everyone, ... (click for more)

Alexander Says Chickamauga Lock Construction Will Continue For 2nd Consecutive Year

Senator Lamar Alexander says the latest Army Corps of Engineers Work Plan includes great news for East Tennessee – and everyone who benefits from river traffic passing through the Chickamauga Lock in Chattanooga. In addition to funding slated for the first three priority projects of the Inland Waterways Trust Fund, the Corps of Engineers’ plan includes $29.9 million to continue ... (click for more)

Bradley County Schools "Very Saddened" By Switch To Pen And Paper Testing

Dr. Linda Cash, director of the Bradley County Schools, said school officials were "very saddened" by the move to pen and paper on taking the TNReady testing after a crash of the online system. She said, "Bradley County Schools would like to thank all of our students and teachers for the hard work you have been doing to prepare for TNReady. However, we are very saddened to hear ... (click for more)

Rick Smith Should Not Be Paid To Leave

Taxpayers of Hamilton County should take note that a majority of the members of the school board are getting ready to give Rick Smith the buyout that he wants.  Do you agree that someone should be paid for taking the coward's way out?  Rick Smith should be fired for cause. Not paid to leave.   If you don't want the board members to pay him off, call or ... (click for more)

Roy Exum: The Momma Bears Roar

If I could count Hamilton County’s best educators on one hand, Normal Park Elementary Principal Jill Levine would be the biggest finger. What she and her faculty and a dazzling commitment from both her students and parents have accomplished is an educational dream. I am told people literally move to North Chattanooga just so their children will be zoned for the award-winning school. ... (click for more)