The U.S. Food and Drug Administration recently sent letters to companies that produce homeopathic products claiming they were in violation of current good manufacturing practice (CGMP) regulations.
The letters were sent to Kadesh, U.S. Continental Marketing, Fill It Pack It, and Bershtel Enterprises.
“It’s our public health obligation to protect consumers from unsafe products. Our manufacturing requirements are designed to ensure the quality and safety of drugs distributed to American consumers, and the FDA expects companies to manufacture and label their products appropriately,” said FDA acting commissioner Ned Sharpless in a press release. “When products labeled as homeopathic are contaminated or contain potentially harmful ingredients, we will take action so consumers are not put at risk.”
David Gortler, a professor of pharmacology and a former FDA official, said the FDA should have more oversight over homeopathic products.
“Homeopathic drugs are concentrations of naturally occurring substances which are not regulated by the FDA,” said Gortler, who consults for the group FormerFDA.com.
“In order for a pharmaceutical product to be eligible for a patent they must fit the criteria of being: 1) non-obvious, 2) novel and have 3) a proven clinical utility.”
Gortler said incomplete clinical research on the ideal dose, drug-drug interactions, long-term or short-term safety and clinical outcomes exist for these mediations because the drugs are un-patentable because they occur naturally.
“Thoroughly testing a drug for clinical utility and safety costs around $3 billion. Spending that amount usually gives a manufacturer about a decade of market exclusivity during which time the manufacturer (hopefully) makes back its clinical testing costs. Since homeopathic drugs are not patent-able, nobody has the motivation to spend the $3 billion testing costs.”
The FDA has almost no regulatory authority over homeopathic drug, according to Gortler,
The policy expert said that has to change.
“The FDA oversight of homeopathic drugs needs to be increased in order to protect the American public. Concentrated homeopathic drugs cause drug-drug interactions with other homeopathic drugs or your regularly prescribed (allopathic) medications or significant safety concerns if taken in excess or used improperly.
“Consumers could additionally be duped by unverified claims made by internet or television and radio ads by individuals such as Dr. Oz who have minimal pharmacology training, and often make unverified claims based on incomplete studies, regarding the purported benefits of these products. Almost all of these ads are not made by healthcare professionals. The companies promoting these products are strictly financially-motivated and do not have the consumers best well-being in mind.”
The FDA press release summed it up this way.
“These unapproved drugs may cause significant and even irreparable harm if they are poorly manufactured, which can lead to contamination, or may contain active ingredients that are not adequately tested or disclosed to patients,” the release said.