Wednesday, May 22, 2013

Senator Mikulski's Remarks regarding Pharmacy Compounding Quality and Accountability Act and the Drug Supply Chain Security Act Moving to Senate Floor

In the next step of the process, the bill will move to the Senate floor for a vote, which has not yet been scheduled.

Senator Mikulski's full remarks as prepared follows:

"Thank you Chairman Harkin and Ranking Member Alexander for engaging stakeholders to improve the safety of our drug supply.

"We are here today to markup two bills that the committee has worked on for more than a year, the Pharmacy Compounding Quality and Accountability Act and the Drug Supply Chain Security Act. We are improving regulation of pharmacy compounding practices and strengthening the security of our drug supply chain to prevent counterfeit and substandard drugs from entering the market. I am so pleased we are working on both of these bills simultaneously, in a bipartisan manner and with input from advocates.

"So much of what we do is about ensuring the safety and efficacy of drugs that are approved by FDA. But this is called into question when illicit, substandard and counterfeit drugs enter the drug supply chain. We have developed a bipartisan, commonsense, achieveable and affordable bill that provides integrity in the supply chain.

"In February at the request of the FDA, the Institute of Medicine (IOM) issued a report that 'assessed the global public health implications of falsified, substandard and counterfeit pharmaceuticals.' IOM called for strengthening the drug distributionsystem through better regulation of the wholesale market.

"I am so pleased Senators Bennet, Burr, Harkin, Alexander and Isakson worked in a bipartisan manner on the Drug Supply Chain Security Act. The bill we are marking up will allow us to verify that drugs are what they claim to be, are correctly handled and not counterfeited or stolen.

"The actions by one compounding pharmacy in Massachusetts, the New England Compounding Center (NECC) left 55 people dead from fungal meningitis. In my own state of Maryland there have been 26 confirmed cases and three deaths. This should never have happened. By all accounts, there are many people and agencies to blame - from the NECC themselves to the Massachusetts Board of Pharmacy. But blame offers no relief to those who have lost a loved one.

"The legislation we passed today is bipartisan, achievable, affordable and doable. It meets compelling human need and puts into place important safeguards to ensure the safety and security of our drug supply chain. I want to thank my colleagues for working closely with the FDA on this bill to make sure that we are giving them the resources and tools they need to do the job we are asking of them.

"Hospitals, doctors and patients are increasingly relying upon 'compounded drugs,' which are supposed to be made on an individual basis to respond to a patient's unique health needs. For instance: if a patient is allergic to a certain ingredient in a drug, a compounding pharmacy can make the drug without that ingredient, or if a child needs a smaller dosage strength, a compounding pharmacy can do that.

"Today one to three percent of the U.S. prescription drug market is made up of compounded drugs. A majority of pharmacists compound medicines for patients and nearly every hospital compounds drugs. These drugs and the hospitals and pharmacies that make them serve an important role for patients that need personalized drugs to meet a medical need.

"The problem is that where there is need, there is greed. Compounded drugs are supposed to be made on an individual basis for an individual patient, and provided only with a prescription from a doctor.

"It has become clear that certain compounding facilities like the NECC were blatantly and flagrantly violating these rules. And why? To make a profit? Not only was NECC mass producing drugs and dispensing them across state lines without prescriptions, NECC also knowingly disregarded sterility tests and prepared drugs in unsanitary conditions. It has become evident to all of us that the regulatory framework in place to catch and prevent these illegal and dangerous practices failed us.

"We cannot undo the tragedy caused by NECC's actions, but we must find a way to prevent this from happening again. This committee has spent the past seven months working to get to the bottom of what went wrong, and develop a regulatory framework with enforcement teeth to prevent another NECC from making drugs that harm patients.

"This bill aims to establish clear boundaries between state roles and responsibilities over pharmacies and FDA's role. We clarify existing FDA authorities in statute which were challenged in federal court by compounding pharmacies. We prohibit all compounders from making certain drug products that are too difficult to compound or undermine FDA's drug approval process, including asthma inhalers, biologics and copies of FDA approved drugs.

"I also fought to make sure that the responsibilities we give to FDA are ones they can handle. We cannot continue to heap new responsibilities on FDA without a corresponding increase in resources and personnel. We need to make sure FDA has the enforcement tools it needs to identify bad actors. We must also have clear distinctions between compounding pharmacy manufacturers and drug manufacturers like Novartis, Pfizer and Teva. We cannot weaken our gold standard for drug approvals by creating a pathway for compounders and drug manufacturers to by-pass the FDA drug approval process.

"I am looking forward to working with my colleagues to refine this bill as it goes to the Senate floor. It's critical that any bill we pass must give FDA the tools and resources they need to do what we are asking of them. We ask FDA to do so much with so little. Thanks again to Chairman Harkin and Ranking Member Alexander for your work on both of these bills."

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