SCOTUS Petition Challenges DEA “Red Flags”

Ronald
Wed, 10 Aug 2022 20:04:12 +0000
Articles, administrative law, appeal, DEA, opioid, pharmacy, red flags, SCOTUS

On the heels of the recent decision in Ruan v. United States, a Florida pharmacy is at the steps of the Supreme Court arguing that the DEA has unconstitutionally encroached on the practice of pharmacies dispensing opioid prescriptions. Should the Supreme Court take up this challenge it would be in a position to extend the Ruan decision to the practice of pharmacy and restrict the DEA’s powers to discipline pharmacists.

SCOTUS Challenge SEEKS to UPEND DEA “red flag” standard

On August 9, 2022, attorney Ronald W. Chapman II filed a petition for certiorari in the United States Supreme Court on behalf of Suntree Pharmacy. A copy of the petition can be downloaded here. Suntree pharmacy was a retail pharmacy in Florida. The DEA filed an order to show cause against the pharmacy seeking to strip Suntree of its DEA registration for failure to document “red flags” on the back of prescriptions. “Red flags” are a common term used for the DEA’s ad hoc list of warning signs that a prescription may be illegitimate. While not formally published in any DEA publication, the DEA typically looks at the distance between the patient and the pharmacy, strength of medication, combination of medications, patients residing in the same household, the taxonomy of the prescriber etc. Suntree’s petition challenges the DEA’s interpretation of its authority and argues that the DEA does not have the authority granted by congress to determine the boundaries of the practice of pharmacy. Suntree also asserts that the DEA must determine that a prescription is actually “illegitimate” before seeking to discipline a pharmacist or pharmacy for filling the prescription.

The DEA Administrative Law Judge prevented SUNTREE from Introducing Evidence of the Prescription’s Legitimacy

Suntree challenged the order to show cause at an administrative hearing before an administrative law judge – employed by the DEA. The judge ruled that the medical necessity of the prescription was irrelevant and that Suntree can be disciplined simply because the pharmacy, according to the DEA, failed to anticipate the DEA’s findings of “red flags” and failed to document the “red flags”. Because the pharmacy could not introduce testimony of the medical providers who prescribed the medication in question or call the patients who received the medications – Suntree was left flat-footed under the weight of the DEA’s “red flag” standard.

SUNTREE’S APPEAL BEFORE THE 11th CIRCUIT

Suntree appealed the DEA administrator’s decision to the 11th Circuit court of appeals arguing that the “red flag” standard is not a medical standard and instead is a law enforcement term essentially made up by the DEA and its prior decisions. This is important because a pharmacy should only be disciplined for failure to adhere to its “corresponding responsibility” found in 21 C.F.R. 1306.04 – the regulation at issue in the recent Supreme Court ruling in Ruan v. United States. The corresponding responsibility requires a pharmacy to ensure that a prescription is legitimate before filling the prescription. It does not require a pharmacist to question the medical judgment of a doctor but rather to exercise their diligence as a pharmacist to look out for problematic drug combinations and to ensure that the prescription was issued by a physician authorized to prescribe.

THE IMPACT OF A CERT GRANT IN SUNTREE

Suntree’s challenge in the Supreme Court is vital to extending the Supreme Court’s decision in Ruan v. United States to the practice of pharmacy. Just as in the Suntree case, the DEA has encroached not only on the medical decision-making of physicians but also the decision-making of pharmacists. This has lead to pharmacies refusing to fill legitimate prescriptions authored by legitimate physicians out of fear of DEA intervention or even criminal indictment. Should the high court take up the Suntree petition, it would be in a position to extend the court’s rationale in Ruan to the practice of pharmacy and prevent pharmacists from scrutiny simply because they failed to anticipate and resolve “red flags”. Moreover, the Court would be in a position to send a strong message to the DEA and DOJ that it does not have the authority to determine the appropriateness of a pharmacist’s practice – it is only authorized to prevent diversion to illegitimate channels.

Review the petition here.