WASHINGTON, D.C.—Today, Senator Tom Harkin (D-IA), Chairman of the Senate Health, Education, Labor, and Pensions (HELP) Committee delivered a speech on the floor of the Senate on the Drug Quality and Security Act.
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 Lamar Alexander (R-TN), Sen. Al Franken (D-MN), and Sen. Pat Roberts (R-KS)—developed legislation to help ensure that quality compounded drugs are available to patients who need them. Additionally, Chairman Harkin and Ranking Member Alexander—along with Sens. Michael Bennet (D-CO) and Richard Burr (R-NC)—have developed track and trace legislation that improves 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. The last comprehensive effort to establish safeguards for the drug distribution supply chain was twenty-five years ago. The Drug Quality and Security Act reflects a bicameral, bipartisan effort to address these drug safety and security issues. More information on the bill is available here.
Following is the full text of his remarks, as prepared for delivery.
"Mr. President, I have high hopes that the Senate will soon vote to enact the Drug Quality and Security Act. This legislation helps ensure the safety of compounded drug products and secure the pharmaceutical supply chain. I am pleased to report that it is the product of excellent bipartisan collaboration on the Health, Education, Labor and Pensions Committee, which I chair, and where I work closely with Ranking Member Alexander. It also reflects productive conversations with our colleagues in the House, including Chairman Upton and Ranking Member Waxman of the House Energy and Commerce Committee. The House passed the Drug Quality and Security Act, or DQSA for short, on September 28th. Now it’s our turn to do our part.
"Title I of the bill addresses drug compounding. Just over a year ago we were all shocked to learn of one of the worst public health crises this country has experienced in recent years: the meningitis outbreak that so far has claimed the lives of 64 Americans and sickened 751 patients in 20 states. This outbreak brought attention to the legal and regulatory gaps that allowed owners and managers at the New England Compounding Center to disregard basic procedures to ensure that the products they were manufacturing were sterile and safe. This gross negligence had heartbreaking consequences for families nationwide.
"The 751 patients who were sickened by contaminated injections sold by NECC, and the families of the 64 who died, have lived a nightmare over this past year. The medicine that was supposed to help them made them gravely ill or, in far too many cases, took their lives. These include patients like:
"Unfortunately, last fall’s outbreak was not an isolated incident. Over the last decade patients have suffered from bloodstream infections, skin abscesses, and even fatal overdoses as a result of compounded drugs that were contaminated or improperly formulated.
"In response to these dismaying facts, beginning last year, Senator Alexander and I convened the members of the HELP Committee – with assistance from Senators Franken and Roberts – in an effort to identify the gaps in current policy, solicit stakeholder views, and craft bipartisan legislation to better ensure the quality of compounded drug products. We formally solicited three rounds of public comment and held two hearings before marking up the bill last May. Then over the summer we worked with our colleagues in the House to craft a package with strong bipartisan and bicameral support.
"The compounding provisions in the DQSA are an unqualified step forward from current law and practice.The bill 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 regulated by State Boards of Pharmacy as they are in current law. An entity that neither stays within the limits of traditional pharmacy compounding nor registers with FDA as an outsourcing facility is illegally selling unapproved drugs, and FDA can take enforcement action against them.
"The legislation defines the Food and Drug Administration’s role in oversight of outsourcing facilities—those facilities that compound large volumes of drugs without individual prescriptions. 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 compounded products from outsourcing facilities that comply with FDA quality standards.
"The bill offers providers and patients better information about compounded drugs. It directs FDA to make a list of FDA-regulated outsourcing facilities available on FDA’s website, requires detailed labeling of compounded drugs, and prohibits false and misleading advertising.
"And finally, the bill 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 for compounding.
"These provisions are a clear example of what Congress can accomplish when both sides come together. Americans deserve to know that their medications are safe, and by improving oversight of high-risk drug compounding facilities, we can make that a reality.
"The track-and-trace provisions of Title II of the Drug Quality and Security Act will revolutionize the pharmaceutical supply chain. In the FDA user fee bill last year, we included important provisions to modernize FDA’s authorities regarding what we call the 'upstream' supply chain – the path drugs take from raw materials to finished pharmaceutical products. This bill completes that work by modernizing the 'downstream' supply chain to better ensure the safety of those finished drug products as they travel from manufacturers to providers and patients. The last comprehensive effort to establish safeguards for the drug distribution supply chain was twenty-five years ago.
"The track-and-trace provisions, which Ranking Member Alexander and I have worked on with Senators Bennet and Burr for almost two years, will replace today’s patchwork of state product tracing laws with a strong, uniform standard that will ultimately result in electronic, interoperable unit level product tracing for the entire country.
"The bill establishes a clear 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 product tracing.
"The legislation 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.
"The bill 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.
"This legislation will help to root out counterfeit and adulterated products before they make their way into the medicine cabinets of American patients. And when a bad product does reach patients, this will allow those products to be identified and recalled more quickly, so people are less likely to be harmed. Over the next decade this bill will transform the pharmaceutical distribution system and enhance security at every step in the chain.
"We – Democrats and Republicans, House and Senate alike – did not get everything each of us wanted in this bill, but the public health problems we are trying to solve here are too important to allow our differences to distract us from the important goal of putting together a bill that everyone could get behind. This is a very good bill that will have a real impact on the safety of the American drug supply.
"As a result, it is widely supported by the patient groups and industry. I have received letters from many groups outlining their support for provisions in this bill. To name just a few, I have received letters from:
"This legislation will help ensure the quality and safety of the drugs patients rely on. I urge my colleagues to join in the bipartisan spirit of cooperation that we have witnessed in our nearly two years of work on this bill. Let us come together to pass this legislation, which is of such critical importance to the American people."