The FDA, Not the CDC, Governs Prescribing Authority

The U.S. Food and Drug Administration (FDA) is the only federal agency that determines and approves the prescribing guidelines for medications in the United States. It publishes official prescribing labels that govern how drugs should be administered, dosed, and titrated by physicians.

By contrast, the Centers for Disease Control and Prevention (CDC) issues public health recommendations, not legally binding rules. While these guidelines can influence medical practices and inform broad strategies to reduce overdose risk, they are not enforceable standards for individual treatment. The CDC itself acknowledges that its 2022 opioid guidelines are voluntary and not intended to serve as a strict limit for prescribing to patients with chronic pain.

FDA Guidelines for Oxycodone

According to the FDA-approved labeling for immediate-release oxycodone:

• Typical adult dosing ranges from 5 to 15 mg every 4 to 6 hours as needed, with higher doses allowable based on patient tolerance.

• There is no established maximum dose, and physicians are directed to titrate upward based on the severity of the patient’s pain and the individual’s prior exposure to opioids.

• The label explicitly supports individualized dosing, particularly in opioid-tolerant patients.

Source: https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208090s015lbl.pdf

CDC Guidelines: Non-Binding, Population-Level Guidance

The CDC’s 2022 guidelines caution providers about opioid risks and recommend limiting opioid prescriptions to 90 MME/day or less in most cases. However:

• These guidelines are not binding and do not override FDA prescribing authority.
• The CDC itself states they are not intended to be applied as inflexible laws or policies.

Source: https://www.cdc.gov/opioids/guideline/index.html

Impact on My Care as a Disabled Patient

I am a clinically disabled individual on SSDI with a complex history of spinal fusion, heart surgery, chronic musculoskeletal pain, and long-standing opioid tolerance. Despite these conditions:

• Five physicians at UC Davis Health have refused to increase my oxycodone dose beyond 90 MME, even when doing so was the only effective and previously safe option.
• These decisions were not based on clinical evidence, patient harm, or FDA limitations but appear to reflect internal adherence to the CDC’s 90 MME “recommendation.”
• Alternative treatments were pushed repeatedly, including three separate forced trials of buprenorphine products (Butrans and Suboxone), despite known cardiovascular risks and prior documented harm.
• I experienced blackouts, orthostatic hypotension, debilitating fatigue, and injury, including falling and sustaining trauma while under the influence of these medications.
• Despite this, no provider was willing to return to the prior regimen that had kept me stable and functioning without side effects for over two years.

Conclusion

UC Davis Health’s continued refusal to prescribe oxycodone above 90 MME appears to be based on institutional policy, not individual clinical judgment. This policy:

• Conflicts with the FDA’s prescribing authority;
• Relies on CDC guidance that is non-binding;
• Results in the denial of effective treatment to a disabled individual;
• Ignores documented harm caused by alternative medications;
• Violates the spirit, if not the letter, of the Americans with Disabilities Act (ADA) and Section 504 of the Rehabilitation Act, both of which require reasonable medical accommodations.

Access to effective pain treatment is a matter of medical equity and disability rights. For patients like me, failure to provide individualized care results not only in unmanaged pain—but in ongoing physical, emotional, and legal harm.

Supporting Materials:

• FDA Guidelines and Maximum Dosage for Oxycodone
• CDC Opioid Guidelines (2022)