WASHINGTON, D.C. — The Food and Drug Administration this past week took several actions that could affect patients, telehealth providers, drugmakers, and state regulators, issuing warning letters over compounded weight-loss drug marketing, seeking public input on at-home opioid disposal systems, approving a new multiple myeloma treatment, and expanding discussions with states about importing lower-cost prescription drugs from Canada.
What This Means for You
- The FDA is warning telehealth companies not to market compounded GLP-1 drugs as if they are the same as FDA-approved medications.
- Patients, providers, and advocates have until April 6 to comment on possible new standards for in-home opioid disposal kits.
- States and tribes exploring prescription drug imports from Canada may receive additional guidance from the FDA during the approval process.
The actions, announced between March 3 and March 6, reflect a broad push by the agency addressing drug advertising, opioid safety, cancer treatment approvals, and prescription drug pricing.
Telehealth Firms Receive Warning Letters
The FDA said it issued 30 warning letters to telehealth companies for making false or misleading claims about compounded GLP-1 products sold through their websites. GLP-1 drugs are a class of medications used to treat conditions such as diabetes and obesity.
According to the agency, the main violations involved claims suggesting compounded products were the same as FDA-approved drugs and marketing practices that made it unclear who was actually producing the medication.
The FDA said compounded drugs are not FDA-approved, meaning the agency does not review their safety, effectiveness, or quality before they reach the market. They are also different from generic drugs, which do undergo FDA review.
“It’s a new era. We are paying close attention to misleading claims being made by telehealth and pharma companies across all media platforms—and taking swift action,” FDA Commissioner Marty Makary said.
FDA Seeks Input on Opioid Disposal
The agency also issued a Request for Information seeking public comment on whether new standards should be developed for in-home opioid disposal products.
Currently, opioid manufacturers are required to make prepaid mail-back envelopes available through outpatient pharmacies and other dispensers. The FDA is now considering whether companies should also be required to provide in-home disposal systems through those same channels.
Makary said unused opioids left in homes can pose risks both to people struggling with addiction and to family members who have never used opioids before.
At present, the FDA recommends dropping off unused opioids at a drug take-back location or mailing them back using a prepaid envelope provided by a pharmacy. For certain high-risk medications, the agency also recommends flushing unused opioids.
Comments on the proposal are due by 11:59 p.m. Eastern Time on April 6, 2026. Interested parties may submit comments through the docket at https://www.federalregister.gov/
New Multiple Myeloma Drug Combo Wins Approval
On March 5, the FDA approved teclistamab in combination with daratumumab hyaluronidase-fihj, known as Tec-Dara, for adults with relapsed or refractory multiple myeloma who have received at least one prior line of therapy.
Multiple myeloma is a blood cancer. The terms relapsed or refractory refer to disease that has returned after treatment or has not responded to earlier therapy.
The agency said the approval came 55 days after the application was filed under the Commissioner’s National Priority Voucher pilot program, which aims to speed review of treatments addressing major health priorities.
According to the FDA, a Phase 3 clinical trial showed the combination reduced the risk of disease progression or death by 83 percent compared with the standard-of-care control group.
The prescribing information includes a boxed warning for cytokine release syndrome and neurologic toxicity. Cytokine release syndrome is a severe inflammatory reaction that can cause high fever, low blood pressure, and, in some cases, death.
Because of these risks, the treatment is available only through a restricted risk management program. The approval was granted to Janssen Biotech, Inc.
States Get More Guidance on Drug Imports
Earlier in the week, FDA officials met with several states to discuss the Section 804 Importation Program, which allows states and Indian tribes to seek permission to import certain prescription drugs from Canada to reduce costs for consumers.
The meeting provided a forum for states to exchange information with federal officials and discuss ways to streamline the authorization process while maintaining safety and quality standards.
The FDA said it is allowing states and tribes to submit draft proposals for pre-review and receive feedback before formally submitting applications.
The agency also launched a quality assurance tool earlier this year to help program sponsors prepare proposals that comply with federal requirements.
“We are committed to lowering prescription drug prices for Americans,” Makary said. “We’re moving forward to implement the president’s executive order as we continue the crucial work of helping states and Indian tribes import reduced cost prescription drugs, while protecting public health and safety.”
Broader Pattern of Agency Action
Taken together, the week’s announcements show the FDA moving on several fronts at once: policing online drug promotion, strengthening safeguards around opioid misuse, accelerating review of certain medical treatments, and assisting states exploring lower-cost prescription drug options.
For consumers, the immediate impacts include stricter oversight of some telehealth drug marketing, a newly approved treatment option for certain multiple myeloma patients, and the possibility of future changes to opioid disposal tools and prescription drug import programs.
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