HOUSTON (March 12, 2013) – Dr. Steven Hotze, CEO and founder of and Hotze Pharmacy, criticized the conclusion of the CBS 60 Minutes report about compounding pharmacies that aired Sunday that essentially advocated for a federal takeover of the regulation of pharmacies by the Food and Drug Administration (FDA).
“Pharmacies and pharmacists are currently licensed and regulated by the states, just as are physicians and dentists. This system should be preserved,” said Dr. Hotze.
At issue in the 60 Minutes story were the actions of New England Compounding Center (NECC) of Framingham, Massachusetts. NECC appears to be a rogue pharmacy that apparently violated both federal and state laws and shipped contaminated steroid injections that have led to the deaths of 48 individuals. Both the Massachusetts Board of Pharmacy and the FDA missed numerous opportunities to either prevent this tragedy or to limit its impact.
“The state of Massachusetts has accepted responsibility for its inaction and has fired those involved,” said Dr. Hotze. “During Congressional and Senate hearings about the NECC case, FDA Commissioner Dr. Margaret Hamburg admitted that the FDA had sent warning letters to NECC, threatening to close it down. Despite this admission, Hamburg refused to accept any responsibility for the FDA regarding NECC, but instead asked for additional authority to control all compounding pharmacies rather than trying to figure out who in the agency failed to take actions that would have saved lives.”
“Over 100,000 individuals die each year in hospitals from doctor prescribed, FDA approved drugs given in the correct dosages,” Dr. Hotze said. “The fact is that FDA approved prescription drugs, when used as intended, are one of the leading causes of death in the U.S. That should cause politicians in Washington to think twice before increasing the FDA’s regulatory authority.”
“The FDA is trying to use this tragedy to gain unprecedented control over the practice of medicine,” Dr. Hotze said. “For over 20 years the FDA has been attempting to curtail the access of physicians and patients to compounded medications, and they see this as their golden opportunity.”
Every year, millions of patients in the U.S. depend on compounded medications to meet needs that cannot be met by manufactured drugs. Compounding pharmacy customizes
medications into dosage and delivery forms that practitioners prescribe to meet the needs of patients. This includes diverse patient groups, such as children with autism, women in menopause, the elderly in a hospice situation, and many others. Compounding is even more prevalent in animal health as medications must be customized to treat dogs, cats and other species ranging from parakeets to elephants. Compounding also keeps thousands of prescription medications available that have been withdrawn from the market by drug companies because they do not generate desired profits or because they compete with newer patented drugs that are much more expensive and profitable.
“If the FDA is successful in controlling and limiting access to compounded medications by doctors and patients, there will be even more suffering and deaths as critical and life-saving therapies will not be available. These deaths won’t be reported by 60 Minutes because they will not be sensational,” said Dr. Hotze.
“The incentive for the FDA is clear,” said Dr. Hotze. “The FDA receives over 25 percent of its budget from drug user fees paid to it by the pharmaceutical companies on FDA approved drugs. They get nothing from compounded medications. The drug companies have become the main client of the FDA and not the American public.”
“If the FDA were to be successful in obtaining the authority over compounding pharmacy that it wants, then it would have to create a huge bureaucracy to regulate tens of thousands of pharmacies that engage in some degree of compounding. This expansion is ridiculous considering the current federal budget deficit. There is already a system in place at the state level that would be duplicated. The emphasis should be on improving state regulation rather than creating a whole new federal structure that would be both inefficient and ineffective,” Hotze added.
“Pharmacies should be regulated by the states. The State Board of Pharmacies issue licenses to pharmacies and pharmacists and are the most knowledgeable about their operations. While the FDA has been trying to cover its tracks and extend its power, the state boards of pharmacy have already begun improving regulations and state laws to ensure that another NECC tragedy does not happen again.”
Hotze Health & Wellness Center is leading the Revolution in Wellness™ care by changing the way women and men are treated in mid-life through the use of biologically identical hormones. Founded in 1989 by Steven F. Hotze, M.D., the Center has successfully treated more than 25,000 patients. In an effort to help patients obtain and maintain life-long health and wellness, physicians and registered nurses on staff address the root cause of symptoms, and correct health ailments naturally rather than merely masking symptoms with drugs. For more information, visit, , and on Facebook: .