Showing posts with label Harkin. Show all posts
Showing posts with label Harkin. Show all posts

Tuesday, August 13, 2013

Harkin Urges Passage of Compounding Bill; The FDA's latest action, involving bacterial infections potentially associated with a compounding pharmacy's product, shows the Pharmaceutical Quality, Security, and Accountability Act should be enacted, the HELP chairman said.

After the FDA announced a nationwide recall of all sterile use products produced and distributed by Specialty Compounding, LLC of Cedar Park, Texas, the office of U.S. Sen. Tom Harkin, D-Iowa, chairman of the U.S. Senate Health, Education, Labor and Pensions Committee, posted an Aug. 10 statement by him imploring the Senate to pass the bill he and committee members of both parties passed to strengthen oversight of compounding pharmacies.
FDA announced the recall had followed reports of bacterial bloodstream infections potentially related to Specialty Compounding's calcium gluconate infusions. Facilities, health care providers, and patients who received them since May 9, 2013, "should immediately discontinue use, quarantine the products, and return the products to Specialty Compounding," the agency announced.
Harkin's statement said 15 patients developed infections. "Though this case is still under investigation by the FDA, this latest in a string of incidents involving compounders brings renewed focus to the U.S. Senate's bipartisan Pharmaceutical Quality, Security, and Accountability Act," it said. "The legislation would improve the safety of compounded drugs by making clear the compounding oversight responsibilities of state and federal authorities. The bill would also protect the nation's drug supply chain by establishing a uniform, national prescription drug-tracing framework. It was approved by the U.S. Senate Health, Education, Labor, and Pensions (HELP) Committee in May, and is now pending consideration by the full Senate."

"I am saddened to learn of yet another incident where patients have been potentially harmed due to tainted drugs produced by a compounder," he said. "The Senate has before it a unique opportunity to take bipartisan action and improve the safety of compounded drugs. I hope that the Senate takes up and passes the bipartisan Pharmaceutical Quality, Security, and Accountability Act as soon as possible so that the FDA and state boards of pharmacy can have the guidance necessary to carry out their work to protect all Americans."
"Because of the potential association between the hospital-based infections and sterile compounded medications produced by Specialty Compounding, we are voluntarily recalling all sterile products out of an abundance of caution," Ray Solano, R.Ph., pharmacist in charge at Specialty Compounding, said in an FDA news release. "We deeply regret the impact this recall has on our patients and the hospitals that we serve, but patient safety must always be our first concern."

quoted from here

Thursday, May 16, 2013

Bennet, Burr, Harkin, Alexander Introduce Bill to Improve Safety of Nation’s Drug Supply

Bill Establishes National Drug Traceability System, Last Comprehensive Drug Distribution Effort 25 Years Ago Helps Secure Drug Supply For Families and Patients
Wednesday, May 15, 2013Liz Wolgemuth 202-228-4729
Washington, DC – U.S. Senators Michael Bennet (D-Colo.) and Richard Burr (R-N.C.) with the Chairman and Ranking Member of the Senate Health, Education, Labor and Pensions Committee, Tom Harkin (D-Iowa) and Lamar Alexander (R-Tenn.) today introduced a bipartisan bill to strengthen and improve our nation’s drug distribution supply chain. The last comprehensive effort to establish safeguards for the drug distribution supply chain was 25 years ago with the passage of The Prescription Drug Marketing Act.
The bill introduced today builds on a yearlong effort to find consensus and incorporates feedback from stakeholders that the senators sought after releasing a draft of the proposallast month. If passed, it would improve patient safety by replacing today’s patchwork of state product tracing laws with a strong, uniform standard that would ultimately result in electronic, interoperable unit level product tracing for the entire country.
“It doesn’t make much sense to me or to anyone back in Colorado that right now, we know more from a barcode on a gallon of milk than from a barcode on a bottle of pills – information that could mean the difference between life and death for someone,” Bennet said. “With the record number of recalls and reports of tainted or ineffective drugs reaching our hospitals and drug stores, it is clear that we must take steps to restore confidence to our nation’s families that our drug supply is safe. This bill will help establish a track-and-trace system that will ensure we can get bad drugs off the shelves as soon as they are discovered.”
“Securing our nation’s drug supply chain is critical to the health and safety of the American people,” said Senator Burr. “The American people deserve the peace of mind to know that the medicines they take are safe and effective. This bill establishes a uniform system that improves the security and safety of drugs for consumers.”
“To ensure the safety and integrity of prescription drugs, it is critical that we know where those drugs go once they leave the manufacturer. When Americans take medicine prescribed by their doctor, they should never have to worry that it is counterfeit or has been adulterated or compromised in any way,” said HELP Chairman Tom Harkin. “I am pleased that the HELP Committee has worked in a collaborative, bipartisan fashion to strengthen our ability to trace drugs through the supply chain, and I hope that we can advance this legislation so doctors, pharmacists, and consumers can know exactly where their prescription medications have been and if there is a problem with a drug, it can be quickly found and taken out of the supply chain.”
“This bill creates a new system for tracking drugs from the instant they leave the manufacturer to the moment you pick them up at the local drugstore. This will help protect consumers and families by improving the safety and security of our medicines in the United States,” Alexander said.
The Drug Supply Chain Security Act would transition the current system to a unit-level tracing system over the course of a decade. It requires the entire drug supply chain, including manufacturers, repackagers, wholesale distributors, third-party logistics providers, and dispensers to pass along transaction information, history, and statements, as applicable, when there is a change of ownership. Additionally, no one in the supply chain would be allowed to accept drugs if this information is not provided as part of the change of ownership.
This bill establishes 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 transaction information and history, as applicable, for each drug product. Within that time, the Food and Drug Administration will publish guidance for the drug supply chain on uniform standards to make an interoperable, electronic drug tracing system, and conduct a small business dispenser assessment to look at the feasibility of this system. The bill also requires the FDA to conduct pilot projects on unit-level tracing as well as hold public meetings to ensure broad stakeholder input on a workable interoperable, electronic unit-level system within a decade.
The proposed bill also strengthens licensure requirements for wholesale distributors and requires FDA to keep a database of wholesalers that will be available to the public through the FDA’s website. This empowers both consumers and members of the pharmaceutical distribution supply chain to identify appropriately licensed wholesalers.
Senators Bennet and Burr have worked together for over a year to create a track-and-trace system that will help secure the nation’s drug supply. The two lawmakers secured language in the Senate FDA user fee bill last year to allow for continued discussions on efforts to protect the supply chain of pharmaceutical drugs. This bill is a result of those efforts to establish a national drug traceability system.
The HELP Committee is expected to consider this bill and a bill to address safety issues at compounding pharmacies at a meeting next week.
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