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Senator Roberts: Patient Safety Demands Tougher Oversight of Compounding Pharmacies


Location: Washington, DC

U.S. Senator Pat Roberts, a long time advocate of clarifying federal oversight of large compounding pharmacies, today said the industry must be examined and oversight improved to protect patient safety following the meningitis outbreak that has killed more than 30 Americans.

Senator Roberts made the following remarks at a hearing of the Senate Health, Education, Labor and Pensions Committee entitled "Pharmacy Compounding: Implications of the 2012 Meningitis Outbreak":

"It is important to outline some the previous actions Members of this Committee and the Senate have taken in the past to review and take action on issues relating to compounding pharmacy.

"I want to begin by thanking Chairman Harkin and Ranking Member Enzi for holding this hearing on a topic that has gained significant and deserved attention over the past few weeks, but is also an issue that many of us on the Committee have worked on for many years and, for some, over a decade.

"First and foremost, I want to start out by reiterating my support for pharmacy compounding. I know compounding serves a very important role for patient: patients who are allergic to certain ingredients found in approved drugs or for children who need a pediatric dosage of a drug.

"Legitimate pharmacy compounding occurs when a patient has a special medical need that cannot be met by an FDA-approved drug. Their physician writes a specific prescription for the patient and then the pharmacist makes the medication for the individual patient.

"This type of compounding should continue and I want to work to ensure that we don't do anything to alter that practice.

"Unfortunately, the more traditional pharmacy compounding is not why we are here today. We are here today because there have been bad actors who are using the good name of pharmacy compounding to mass produce products not approved by the FDA and provide them to patients. Compounded products are made for the individual patient and are therefore not FDA-approved.

"However, under the guise of traditional compounding, some manufacturers have been mass producing and providing products without the knowledge of the patient or their doctor.

"Regrettably, this is not a new issue; there have been many examples of injuries and deaths from unsafe compounded drugs that stretch across the country. In fact, it goes back over a decade or more. Throughout that time I have had the privilege of working with many Members of this Committee, especially Senator Burr, on issues related to pharmacy compounding.

"This is an issue that hit far too close to home in Kansas: several years ago a pharmacist in Kansas City was found to be diluting cancer drugs for his patients. Unfortunately, over 4,000 patients were affected before authorities could stop him. Senator Kit Bond and I worked together at that time to hold the first HELP Committee hearing on pharmacy compounding, we requested a GAO report on the status of pharmacy compounding to try to get some answers.

"We sponsored, with what I always thought was, a very simple amendment to the Medicare Modernization Act to have the FDA establish a committee to look into pharmacy compounding and make any recommendations to improve and protect patient safety. This committee was to terminate after one year. This was an amendment supported in the Senate; it was unfortunately stripped during conference because folks incorrectly thought that the states were adequately regulating such pharmacies and that additional federal regulation would be an undue burden.

"I must say, as a member of the Senate who has time and again fought against additional federal regulation and placing undue burden on my constituents, including my local community pharmacists, I was amazed.

"Fast forward a few years later, with Chairman Kennedy and Senator Burr we once again tried to take a closer look at the regulation and enforcement of pharmacy compounding. In an effort to be open and transparent we produced a discussion draft along with Ranking Member Enzi and Senator Reed and requested comments and feedback.

"While I don't think that discussion draft is anything that I would recommend signing into law today, the intent was to garner stakeholder feedback and apply it to our policy making. Instead, rather than working with us, we were faced with a full on grassroots effort to stop the discussion draft from moving forward. I said then, and I would repeat now, that my intent, and I believe the intent of others, was never to do away with pharmacy compounding.

"What we needed were answers. What we got was pushback.

"While it was ultimately Chairman Kennedy's decision not to move forward with the discussion draft, I had hoped then, and continue to believe it is important today, to revisit the regulation, oversight and enforcement of pharmacy compounding at the federal AND state levels. Because, let's face it ladies and gentlemen, something is slipping through the cracks or we would not be here today. There are obviously serious patient safety concerns.

"I have my own opinions on where the cracks may be and ways to address these safety concerns. To that end, I am working with my colleagues on the HELP Committee to discover the appropriate measures we need to put in place to protect patient safety.

Let me be clear, I have not and will not introduce any sort of legislation to ban pharmacy compounding.

"However, the recent and repeated loss of life has reiterated the need for appropriate measures to be put in place to ensure that bad actors can no longer take advantage of patients. Patients have a right to know when they are receiving a product that is not FDA-approved and the risk that may come with using it.

"As I said during the last hearing we had on this subject, I fully recognize the benefits of compounding pharmacy and they fill an important niche in the health care delivery system. However, many questions need to be answered. How do we define manufacturing versus compounding? What are we doing at the state level to enforce regulations currently on the books? How can we get states that do not have adequate regulations on the books to improve? Are those who are inspecting properly trained? Should we have a means to test products once they have been compounded to ensure they are safe and accurate doses? Are schools of pharmacy properly training individuals to compound and what steps they should take to do so safely? Why is there not a system of adverse event reporting? These questions were important a decade ago, and unfortunately they continue to remain relevant today.

"My expectation from today's hearing is to answer some of these questions, learn more about the current state of regulation of pharmacy compounding, and I expect all of our witnesses to commit to working fully with this committee to address any potential gaps in the regulatory structure that would potentially affect patient safety. I hope that today's witnesses will offer their commitment to work with us, and to do so in good faith and with the intent to be transparent and forthcoming in their thoughts, suggestions and concerns."

Senator Roberts is a member of the Senate Health, Education Labor and Pensions Committee.

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