AAHP Reinforces MediNatura’s Defense Against FDA Action
In support of our member company MediNatura, Inc. challenging FDA’s attack on its prescription injectable homeopathic products, AAHP filed an amicus brief in the United States District Court for the District of Columbia on Aug. 28.
On June 11, 2020 FDA sent warning letters to AAHP members MediNatura and Hevert Pharmaceuticals along with two other distributors of homeopathic injectable Rx products, alleging that the products were unapproved new drugs which might be dangerous. On the same day, FDA added MediNatura’s and Hevert’s injectable products to the agency’s Import Alert list, which essentially directs FDA import operations to refuse to admit the products that are imported from Europe into the United States. In a press release about the warning letters, FDA said that:
"The FDA is particularly concerned about unapproved injectable drug products labeled as homeopathic because they are injected directly into the body, often directly into the bloodstream and bypass some of the body's key natural defenses against toxins, toxic ingredients and dangerous organisms that can cause serious and life-threatening harm. Additionally, unapproved drugs that claim to cure, treat or prevent serious conditions may cause consumers to delay or stop medical treatments that have been found safe and effective through the FDA review process."
Despite FDA’s claimed safety concerns, it appears that the products sold by MediNatura and Hevert have a low or non-existent number of serious adverse event reports and FDA cited no specific dangers. (AAHP has no information on the adverse event reports, if any, of the other two companies.)
On July 29, MediNatura filed a complaint against FDA challenging the legality of the agency’s actions. Three days later, MediNatura filed a Motion for a Preliminary Injunction, or, in the Alternative, for a Temporary Restraining Order that would bar FDA from enforcing the Import Alert as to its products pending the outcome of its case. The case has been briefed and the oral telephonic argument was held on Sept. 3. A decision may be announced by the court by the end of the month.
At the request of MediNatura, AAHP sought and received permission to file an amicus (“friend of the court”) brief addressing the safety of homeopathic drugs generally.
Additional amicus briefs were filed by the American Institute of Homeopathy, Americans for Homeopathic Choice, and Chuck Little.