Telehealth GLP-1 Letters Show How FDA Polices Prescription Drug Marketing

The Food and Drug Administration said on March 3 that it had issued 30 warning letters to telehealth companies over false or misleading claims about compounded GLP-1 products offered on their websites. In its announcement, the agency said the main violations were claims implying the compounded drugs were the same as FDA-approved products, and advertising products under a telehealth firm's own name or trademark "without qualification, implying they are the compounder."

FDA called this the second group of warning letters to telehealth firms since it began a crackdown on misleading direct-to-consumer drug advertising in September. It said that over the past six months it had sent thousands of letters asking pharmaceutical and telehealth firms to remove misleading ads, more than it had sent over the entire preceding decade. Commissioner Marty Makary said compounders "should not try to compound drugs in a way that circumvents FDA's approval process." The announcement did not name the companies that received letters.

The letters draw on a part of drug law that gets less attention than approvals: the rules on what may be said about a drug once it is sold.

Who reviews drug promotion

Inside FDA's drug center, the Office of Prescription Drug Promotion reviews prescription drug advertising and promotional labeling to make sure the information is not false or misleading. The office lists its tasks as commenting on proposed promotional materials, reviewing complaints, comparing how related products are promoted and "initiating compliance letters on promotional communications that are false or misleading." Its Bad Ad Program asks doctors, nurses and pharmacists to report potentially misleading promotion, and the office's compliance letters are posted on FDA's warning letter and untitled letter pages.

The underlying rules are in the misbranding section of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 352. A prescription drug is misbranded unless its advertisements carry a true statement of the drug's established name, its quantitative formula and a brief summary of side effects, contraindications and effectiveness. The same paragraph says that, except in extraordinary circumstances, no FDA regulation may require prior approval of an advertisement's content, so enforcement generally comes after an ad appears. For TV and radio ads that name a drug and its use, the main statement of side effects and contraindications must be presented "in a clear, conspicuous, and neutral manner."

The office's frequently asked questions page says ads "cannot be false or misleading or omit material facts" and must present "a fair balance between effectiveness and risk information." FDA's final rule on the clear, conspicuous and neutral standard for broadcast ads took effect on May 20, 2024, with a compliance date of Nov. 20, 2024, according to the same page.

Why compounded drugs are a separate case

Compounded drugs are not FDA-approved, which means the agency does not verify their safety, effectiveness or quality before they are marketed, according to FDA's compounding questions and answers. Pharmacists in state-licensed pharmacies and physicians compound under section 503A of the act, and state boards of pharmacy generally handle day-to-day oversight of those pharmacies. Outsourcing facilities registered under section 503B are primarily overseen by FDA and inspected on a risk-based schedule. A compounded drug is also not a generic: FDA says generics are approved under section 505(j), including a showing of therapeutic equivalence to a brand-name drug.

Congress wrote a specific marketing rule for them. Paragraph (bb) of the misbranding section says a drug is misbranded "If the advertising or promotion of a compounded drug is false or misleading in any particular." FDA's compounding page says promotion disseminated by or on behalf of drug manufacturers, "including compounders," must be truthful, non-misleading and accurate, and that when FDA has concerns it may seek voluntary compliance from the manufacturer, packer or distributor responsible for the material.

The same page notes that people who buy compounded drugs through online pharmacies and telehealth platforms may not know the identity of the compounder that made the drug, the issue FDA's March 3 letters raised about firms that put their own brand names on products they did not compound.