SUPPLEMENTARY INFORMATION:

I. Background

Section 306(a)(2)(B) of the FD&C Act mandates permanent debarment of an individual from providing services in any capacity to a person that has an approved or pending drug product application if FDA finds that the individual has been convicted of a felony under Federal law for conduct relating to the regulation of drug products under the FD&C Act. Separately, section 306(b)(3)(C) of the FD&C Act permits FDA to debar an individual from importing or offering for import into the United States a drug if the Agency finds that the individual has been convicted of a felony under Federal law for conduct relating to the importation into the United States of any drug or controlled substance. On December 16, 2024, following a jury trial, the U.S. District Court for the District of Massachusetts entered a judgment against Dr. Shafa for multiple offenses, including the four felony convictions underlying the bases for these two debarments: three counts of importing merchandise contrary to law in violation of 18 U.S.C. 545, and one count of receiving and delivering a misbranded drug in violation of sections 301(c) and 303(a)(2) of the FD&C Act (21 U.S.C. 331(c) and 333(a)(2)). On February 12, 2025, the court sentenced Dr. Shafa to 36 months in Federal prison and restitution.

By letter dated September 15, 2025 (hereafter “Notice of Opportunity of Hearing” or “NOOH”), FDA's Office of Inspections and Investigations (OII) notified Dr. Shafa of a proposal to issue an order permanently debarring him from providing services in any capacity to a person with an approved or pending drug product application and debarring him for 20 years from importing or offering for import any drug into the United States. As explained in the NOOH, Dr. Shafa's convictions stemmed from his actions while he owned and operated Novel Psychopharmacology.

As described in the NOOH, from on or before January 2008 to on or about January 2018, Dr. Shafa purchased disulfiram pellet implants, disulfiram injections, and naltrexone pellet implants from an overseas supplier and had them unlawfully shipped from Hong Kong to him on multiple occasions. The articles shipped to him were drugs under section 201(g)(1) of the FD&C Act (21 U.S.C. 321(g)(1)) in that they were intended to treat Dr. Shafa's patients for alcohol and opioid dependence. As stated in the NOOH, the drugs at issue were not FDA-approved for these uses in the United States. As further outlined in the NOOH, Dr. Shafa agreed with the supplier that it would falsify the shipping documents to conceal the actual contents of the ( printed page 55888) packages of disulfiram pellet implants, disulfiram injections, and naltrexone pellet implants sent to him. The contents of the packages Dr. Shafa's supplier used included descriptions such as “plastic beads in plastic tubes” and listed values below the actual value of the drugs. Knowing that the actual contents of the packages had been concealed, Dr. Shafa accepted the packages the supplier sent containing the disulfiram pellet implants, disulfiram injections, and naltrexone pellet implants. Dr. Shafa then administered the drugs to patients. Several of Dr. Shafa's patients experienced complications from the procedures or did not find the drugs effective. Despite reports of complications and complaints of ineffectiveness, Dr. Shafa continued to administer the unapproved drugs to patients.

The NOOH explained that the proposed permanent mandatory debarment from providing services to a person with an approved or pending drug application was based on his felony convictions and that the conduct underlying the convictions related to the regulation of drug products under the FD&C Act. The NOOH explained that the proposed 20-year permissive debarment related to drug importation was also based on his felony convictions and that the conduct underlying the convictions related to the importation of drugs into the United States. The NOOH explained that the maximum period of debarment from drug importation for an individual subject to permissive debarment for a felony under section 306(c)(2)(A)(iii) of the FD&C Act is 5 years and that the debarment periods may run consecutively or concurrently.

The NOOH also outlined findings concerning the three relevant factors that OII considered in determining the appropriateness and period of debarment from drug importation under section 306(b)(1)(D) of the FD&C Act, as provided in section 306(c)(3): (1) the nature and seriousness of any offense involved, (2) the nature and extent of voluntary steps to mitigate the impact on the public of any offense involved, and (3) prior convictions under the FD&C Act or under other Acts involving matters within the jurisdiction of FDA. OII found that the nature and seriousness of the offenses and the nature and extent of voluntary steps to mitigate the effect on the public are unfavorable considerations for Dr. Shafa. OII found the lack of prior convictions involving matters within FDA jurisdiction as a favorable consideration for Dr. Shafa. OII concluded that the facts supporting the unfavorable factors outweigh those supporting the favorable factor, thereby warranting a 20-year debarment from drug importation, 5 years for each conviction to run consecutively. The NOOH also provided Dr. Shafa with an opportunity for him to request a hearing under section 306(i) of the FD&C Act and part 12 (21 CFR part 12).

In response to the NOOH, in a letter dated October 2, 2025, Dr. Shafa requested a stay “of any proceeding” due to an appeal of his convictions. On October 6, 2025, Dr. Shafa submitted a timely hearing request and notice of appearance. Dr. Shafa reiterated that he was requesting a hearing “following the fulfillment of my litigation, appeal process, and completion of my sentencing.” On November 19, 2025, the Director of the Office of Scientific Integrity (OSI Director) denied Dr. Shafa's request to stay the matter and gave Dr. Shafa until December 19, 2025, to submit analyses and information in support of his hearing request. On December 10, 2025, Dr. Shafa submitted additional information.^[1] Dr. Shafa's response challenges the proposed debarments on the grounds that he was wrongfully accused and convicted of the offenses at issue and that he has appealed his convictions. Additionally, Dr. Shafa contends that there are material factual disputes concerning the circumstances of his convictions, the medical necessity of the procedures identified in the NOOH, and “irregularities that affected the outcome.”

Under the authority delegated to him by the Commissioner of Food and Drugs, the OSI Director has considered Dr. Shafa's request for a hearing. Hearings are granted only if there is a genuine and substantial issue of fact. A request for a hearing may not rest on mere allegations or denials but must present specific facts showing that there is a genuine and substantial issue of fact that justifies a hearing. Hearings will not be granted on issues of policy or law, on mere allegations, denials or general descriptions of positions and contentions, or on data and information insufficient to justify the factual determination urged (see § 12.24(b)).

II. Analysis

As an initial matter, Dr. Shafa challenges his proposed debarment under sections 306(a)(2)(B) and 306(b)(3)(C) of the FD&C Act by contending, “I was wrongfully accused[,] and my conviction is under appeal.” Pursuant to section 306(l) of the FD&C Act, however, a person is deemed to have been convicted of a criminal offense when a judgment of conviction has been entered against the person by a Federal or State court, regardless of whether there is an appeal pending. Dr. Shafa does not dispute that the U.S. District Court for the District of Massachusetts entered the judgment of convictions underlying the proposals to debar him. Under section 306(l) of the FD&C Act, a pending appeal is not a ground for postponing either ruling on a hearing request or conducting a hearing on a proposed debarment. If Dr. Shafa's appeal ultimately results in the convictions being overturned, he may seek termination of his debarment (see section 306(d)(B)(ii) of the FD&C Act).

Dr. Shafa further maintains that “an evidentiary hearing is required [for] debarment.” Under § 12.24(b), however, FDA may deny a hearing request if there are no factual issues suitable for a hearing. “FDA may deny a request for a hearing unless `the [hearing request] . . . identif[ies] a material issue of fact'” ( Vanda Pharms., Inc. v. U.S. FDA, 150 F.4th 563, 573 (D.C. Cir. 2025) (quoting Am. Cyanamid Co. v. FDA, 606 F.2d 1307, 1314 (D.C. Cir. 1979)) and citing § 12.24(b); see also Costle v. Pacific Legal Found., 445 U.S. 198, 214 (1980) (a party seeking a hearing is required to meet a “threshold burden of tendering evidence suggesting the need for a hearing”), reh'g denied, 446 U.S. 947 (1980), citing Weinberger v. Hynson, Westcott & Dunning, Inc., 412 U.S. 609, 620-21 (1973); Pineapple Growers Ass'n v. FDA, 673 F.2d 1083, 1085-86 (9th Cir. 1982) (holding that no hearing is necessary unless “material issues of fact” have been raised)).

In support of his hearing request, Dr. Shafa nonetheless contends that there are four areas in which there are material factual disputes: (1) “whether the alleged conduct constitutes willful wrongdoing,” (2) whether the medical procedures and drugs used performed to clinical standards, (3) whether evidence exists that undermined the proceeding, such as “clear determining exculpatory evidence,” and (4) whether the purchase of implants was strictly for patients' personal use and compatible with personal importation law. Additionally, Dr. Shafa states that he has maintained all required continuing medical ( printed page 55889) education requirements and that he has never had disciplinary proceedings against him by the Massachusetts Board of Medicine for his medical practice.

A. There Are No Genuine and Substantial Issues of Fact Warranting a Hearing on Whether Dr. Shafa Is Subject to Debarment Under Sections 306(a)(2)(B) and 306(b)(3)(C) of the FD&C Act

Under section 306(a)(2)(B) of the FD&C Act, an individual convicted of a Federal felony for conduct relating to the regulation of drug products under the FD&C Act is subject to permanent debarment. Further, section 306(b)(3)(C) of the FD&C Act authorizes FDA to debar an individual from importing or offering for import into the United States a drug if the Agency finds that the individual has been convicted of a felony under Federal law for conduct relating to the importation into the United States of any drug or controlled substance. The relevant factual considerations as to whether Dr. Shafa is subject to debarment under these provisions are whether he was convicted of a felony under Federal law and whether the conduct underlying the convictions related to the regulation of drug products and the importation into the United States of any drug or controlled substance.

As explained in the NOOH, Dr. Shafa was convicted of three counts of importing merchandise contrary to law in violation of 18 U.S.C. 545 and one count of receiving and delivering a misbranded drug in violation of section 301(c) and 303(a)(2) of the FD&C Act. Dr. Shafa does not deny that he was, in fact, convicted of those violations. As explained above, Dr. Shafa's appeal of those convictions does not affect whether he is currently subject to debarment. Furthermore, there is no genuine and substantial issue of fact as to whether the conduct underlying the convictions related to both the regulation of drug products and the importation of drug products into the United States. As described in the NOOH, the conduct underlying Dr. Shafa's convictions included his coordinating the shipment of unapproved and misbranded drugs into the United States and the falsification of the labeling to conceal the actual contents of the shipments. The criminal proceedings further establish that Dr. Shafa administered the unapproved and misbranded drugs to patients. The conduct underlying Dr. Shafa's felony convictions thus relates to both the regulation of drug products and the importation of drugs into the United States.

In short, there is no dispute as to whether Dr. Shafa's four felony convictions and underlying conduct relate to both the regulation of drug products under the FD&C Act and the importation of drugs into the United States. Therefore, Dr. Shafa has failed to justify a hearing on whether he is subject to debarment under either section 306(a)(2)(B) or 306(b)(3)(C) of the FD&C Act.

B. There Is No Genuine and Substantial Issue of Fact Warranting a Hearing Regarding the Proposed Permissive Debarment

Having determined that Dr. Shafa is subject to mandatory debarment under section 306(a)(2)(B) of the FD&C Act and permissive debarment under section 306(b)(3)(C) of the FD&C Act, FDA then must determine the debarment period for the permissive debarment.

In considering the appropriateness and period of proposed debarment relating to the importation into the United States of a drug or controlled substance, FDA considers the factors outlined in section 306(c)(3) of the FD&C Act where applicable. As explained above, OII determined that the applicable factors for the appropriateness and period of Dr. Shafa's debarment, as provided in section 306(c)(3) of the FD&C Act were (1) the nature and seriousness of any offense involved; (2) the nature and extent of voluntary steps to mitigate the impact on the public of any offense involved; and (3) prior convictions under the FD&C Act or under other Acts involving matters within the jurisdiction of FDA. Given these considerations, OII proposed that Dr. Shafa be debarred for a total of 20 years from importing drugs or offering drugs for import into the United States, by imposing a period of 5 years for each conviction and running those periods consecutively.

Dr. Shafa does not specifically address the factors underpinning the proposed total debarment period of 20 years; however, FDA construes several of his arguments as attempts to mitigate the nature and seriousness of his offense under section 306(c)(3)(A) of the FD&C Act. In arguing that he should not be debarred from importing drugs into the United States on the basis of his felony convictions, Dr. Shafa contends that he did not act with an intent to defraud. He also argues, in essence, that his purchase of the drugs in question was consistent with FDA's exercise of enforcement discretion as to personal importation law. Dr. Shafa further contends that he complied with reporting his medical procedures to the Massachusetts Board of Medicine and that the board never levied any restrictions or penalties regarding the procedure or his use of the implants. He also states that “The District Administration Law Hearing . . . on behalf of the Medical Board of Massachusetts” found that his practice was compatible with “Standard Care” medical practice.

Dr. Shafa's felony convictions under 18 U.S.C. 545 required the jury to find that he “fraudulently or knowingly, with intent to defraud the United States” smuggled merchandise into the country, and his conviction under section 303(a)(2) of the FD&C Act required the jury to find that he violated section 301(c) of the FD&C Act “with an intent to defraud or mislead.” Indeed, the criminal proceedings established that Dr. Shafa coordinated shipping unapproved and misbranded drugs into the United States and concealing their identity through false and misleading shipping documents and that he then administered the drugs to patients. His claim that he did not act with an intent to defraud thus does not raise a material factual dispute suitable for a hearing given the evidence adduced at trial and the elements of the offenses for his convictions. Furthermore, as OII stated in the NOOH, the drugs in question posed significant risks to Dr. Shafa's patients because they had not been reviewed by FDA for safety, effectiveness, or quality and thus determined to be safe and effective for their intended uses. The deceptive conduct underlying Dr. Shafa's convictions—which is not in dispute and involved concealing the identity of such drug products from the government—was sufficiently egregious to warrant OII's conclusion that the nature and seriousness of Dr. Shafa's offenses constitute an unfavorable consideration under section 306(c)(3)(A) of the FD&C Act. Dr. Shafa's arguments regarding FDA's personal importation policy and his medical practice simply fail to counter OII's conclusion regarding the nature and seriousness of his offenses under section 306(c)(3)(A) of the FD&C Act to a degree sufficient to raise a genuine and substantial issue of fact with respect to that consideration. Therefore, the OSI Director treats this consideration as unfavorable.

In the NOOH, OII stated that it was unaware of any steps Dr. Shafa took to mitigate the impact on the public of his actions. Dr. Shafa has not presented any information or analysis addressing this factor; therefore, he failed to raise a genuine and substantial issue of fact with respect to the nature and extent of ( printed page 55890) voluntary steps to mitigate the impact on the public. Consistent with OII's findings in the NOOH, the OSI Director will thus treat this consideration as unfavorable.

Based on the undisputed record, a 20-year debarment period is appropriate. Although it is undisputed that Dr. Shafa has no previous criminal convictions related to matters within the jurisdiction of FDA, this single favorable factor does not counterbalance the nature and seriousness of his offense and lack of voluntary steps promptly taken to mitigate the impact of his offense on the public. Therefore, the OSI Director concurs with OII's conclusion that “the facts supporting the unfavorable factors outweigh those supporting the favorable factor and therefore warrants the imposition of a twenty-year period of debarment, five years for each conviction.”

III. Findings and Order

Therefore, under section 306(a)(2)(B) of the FD&C Act and authority delegated to him by the Commissioner of Food and Drugs, the OSI Director finds that Dr. Shafa has been convicted of a felony under Federal law for conduct relating to the regulation of drug products under the FD&C Act. The OSI Director also finds that Dr. Shafa has been convicted of a felony under Federal law for conduct relating to the importation into the United States of any drug or controlled substance and is subject to debarment as set forth in section 306(b)(3)(C) of the FD&C Act. The OSI Director considered the applicable factors listed in section 306(c)(3) of the FD&C Act and determined, based on the undisputed record before him, that debarring Dr. Shafa for 20 years from importing or offering for import into the United States any drugs is appropriate.

As a result of the foregoing findings, Dr. Shafa is permanently debarred from providing services in any capacity to a person with an approved or pending drug product application under sections 505, 512, or 802 of the FD&C Act (21 U.S.C. 355, 360b, or 382), or under section 351 of the Public Health Service Act (42 U.S.C. 262), effective August 31, 2026 (see 21 U.S.C. 335a(c)(1)(B) and (c)(2)(A)(ii) and 21 U.S.C. 321(dd)). Any person with an approved or pending drug product application, who knowingly uses the services of Dr. Shafa, in any capacity during his period of debarment, will be subject to civil money penalties (section 307(a)(6) of the FD&C Act (21 U.S.C. 335b(a)(6))). If Dr. Shafa, during his period of debarment, provides services in any capacity to a person with an approved or pending drug product application, he will be subject to civil money penalties (section 307(a)(7) of the FD&C Act). In addition, FDA will not accept or review any abbreviated new drug applications submitted by or with the assistance of Dr. Shafa during his period of debarment (section 306(c)(1)(B) of the FD&C Act).

Additionally, as a result of the foregoing findings, Dr. Shafa is debarred for a period of 20 years from importing or offering for import any drug into the United States, effective August 31, 2026. Pursuant to section 301(cc) of the FD&C Act, the importing or offering for import into the United States of any drug by, with the assistance of, or at the direction of Dr. Shafa, is a prohibited act.

91 FR 55886