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FDA Ratchets Up Pressure on Homeopathic Drug Manufacturers

On May 14, FDA announced that it issued five Warning Letters to companies that manufacture and market homeopathic drugs for human use. Four of the letters were issued to four companies that jointly manufacture and package homeopathic eye drops which are indicated for use after eye surgery (e.g., surgery for cataracts or glaucoma). The fifth letter went to a manufacturer of human drugs labeled as homeopathic remedies for, among other things, serious diseases or conditions such as blood poisoning, liver disorders, chicken pox, measles, mumps, suicidal tendencies, and complications relating to pediatric vaccinations. The letters all cite cGMP deficiencies relating to inspectional observations and conclude that the products are misbranded prescription drugs under the Federal Food, Drug, and Cosmetic Act because “in light of their toxicity or other potentiality for harmful effect, or the method of their use, or the collateral measures necessary to their use, they are not safe for use except under the supervision of a practitioner licensed by law to administer such drugs” and they are not labeled for prescription use only.

In 2019 so far, FDA has issued Warning Letters to eleven separate homeopathic drug manufacturers, including the five letters referenced above. All of the Warning Letters, except one, cite observations from inspections and focus on cGMP and quality violations at the manufacturing facilities, including contamination and varying amounts of active ingredients, that could lead to consumer harm. One of the Warning Letters is not linked to an inspection but references claims on the manufacturer’s website indicating that the products are intended for prevention or treatment of serious or life-threatening diseases or conditions.

The eleven Warning Letters are consistent with FDA’s revised guidance and enforcement policy for human homeopathic drugs, announced in draft form on December 18, 2017 (see our previous comment on the draft guidance here), which includes the following risk-based enforcement priorities:

  • Products with reported safety concerns;

  • Products that contain or claim to contain ingredients associated with potentially significant safety concerns;

  • Products for routes of administration other than oral and topical;

  • Products intended to be used for the prevention or treatment of serious and/or life-threatening diseases and conditions;

  • Products for vulnerable populations; and

  • Products that do not meet standards of quality, strength or purity as required under the law.

While the revised enforcement policy is intended to supersede the existing homeopathic drug compliance policy from 1988, FDA has not yet finalized the revised policy. The proposed draft guidance garnered almost 3,250 comments after the comment period was extended to May 21, 2018, and it is likely taking FDA a significant amount of time to review and consider those comments in preparing a final version of the guidance. Regardless, FDA appears to have adopted the revised policy and is carrying out enforcement actions that are consistent with it. The increased activity so far this year could indicate that FDA is moving closer to finalizing the revised enforcement policy, but it is too soon to tell.

We will keep monitoring the status of the guidance and will report on it when FDA releases the final version.

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Benjamin advises pharmaceutical, medical device and biotech companies on the FDA regulatory process to identify the correct regulatory pathway, assisting with FDA communications and strategy.