Pfizer Inc Eastern Point Road Groton, CT 06340 Tel 860 441-8377 Email: gloria.j.gaito@pfizer.com Worldwide Research and Development June 21, 2018 James G. Lavery, Director Bureau of Health Professions Licensure Massachusetts Department of Public Health 250 Washington Street Boston, MA, 02108-4619 Dear Atty. Lavery, Please accept these comments from Pfizer Inc on proposed amendments to 105 CMR 700.000, Implementation of M.G.L. c. 94C. Pfizer is a biopharmaceutical company with a discovery research facility located at 1 Portland Street, Cambridge MA. At this facility, we conduct preclinical research on mice, rats, hamsters and guinea pigs using proprietary compounds, and are committed to the humane care and use of our animals, for the improved health and well-being of people, and the environment. We recently experienced difficulties in renewing our licenses to acquire, use and dispense controlled substances for the care of our laboratory research animals. There were new requirements being placed upon us as part of our license renewal process, and, when attempting to gain clarification of these new requirements, it was difficult to locate staff in the Drug Control Program office. This resulted in significant confusion and uncertainty about our ability to continue our research projects without interruption. We are concerned that the proposed regulations may hinder our ability to humanely conduct biomedical research. We are presenting these comments in the hope that the Department will continue working to modify its regulations to remove some of the administrative and regulatory barriers it may have unknowingly created. Our concerns fall within three general categories. The first has to do with the definition of research drugs and its applicability to animal research as opposed to human clinical trials. It would appear that the Department has unwittingly conflated human and animal clinical research studies with preclinical animal research studies in drafting the proposed regulations. DPH’s proposed regulations define research drug as “… an investigational new drug, as defined by 21 CFR 312.3, or any scheduled drug, which is being used in a research study or program, where it will be administered or dispensed to one or more human or animal subjects.” However, the term “research drug” (105 CMR 700.001) to a pharmaceutical or biotechnology company is any novel drug tested in preclinical (i.e., animal) research prior to Investigational New Drug filing. DPH’s proposed definition extends beyond the Drug Enforcement Agency (DEA) classification of controlled drugs (I-V), and, in creating this new, broadened definition, treats preclinical (animal) and clinical (human or animal) trials as one and the same. The second issue has to do with registration requirements for “primary” investigators. In biomedical research, we commonly refer to “Principal Investigators” or “PIs” and would suggest this terminology to align with the longstanding nomenclature in the field. We are concerned about the significant administrative burden that will be created by requiring individual registrations for each research project being conducted by a primary investigator, as opposed to a single registration from that primary investigator, as has been longstanding practice in the Department. Third, the proposed regulations do not distinguish between studies where the narcotic is the subject of the study, and the far larger number of cases where controlled substances are required for the humane care of the animals used in research (that is, for the provision of anesthesia, analgesia, or euthanasia). We are also concerned that such an interpretation could increase the risk of diversion. Currently, some departments or research groups maintain one registration for several studies when only anesthesia, pain relief or euthanasia is required. Requiring all PIs to register their own research project as well as the authorized staff providing care, would increase institutional drug volumes and storage sites of anesthetic and analgesic controlled drugs and potentially create an increased risk of diversion. We commend the DPH in its efforts to attempt to reduce administrative burden and redundancy by striking the list of application requirements in 700.004 and 700.009. We are concerned however, that removing the known requirements in favor of the Commissioner’s discretion leaves this open to requests for any number of documents and information from the applicant. This situation occurred earlier this year when we received a checklist of several new additional items to be completed before a renewal application could be considered. This caused undue delays with processing our renewal for ongoing research projects with no added benefit at controlling diversion. Receipt of a research registration in a timely manner is imperative to continuing research activities at our facility in in MA. We understand and appreciate the intent of the Department to provide more accountability and safeguards against the misuse of narcotic drugs in the Commonwealth. Certainly, as biomedical researchers, we recognize the scourge of opiate addiction, in particular as a public health policy issue that needs to be addressed. As biomedical researchers committed to the humane care and use of animals in research, we are alarmed at the possibility the new regulations may leave us unable to acquire necessary drugs to prevent and treat pain. We are further concerned that in attempting to try to cover every eventuality or circumstance under which such narcotic misuse may occur, the Department has unintentionally created new regulatory and administrative obstacles that will place our biomedical researchers at a significant disadvantage as opposed to other jurisdictions, and may cause them to cease or transfer elsewhere their research projects. Thank you for the opportunity to provide public comment on these proposed regulations. We stand ready and willing to assist your process in any way we are able and appreciate the efforts you are taking in trying to reduce regulatory burden on our industry. Regards, Gloria Gloria J.Gaito, MBA, MS Executive Director, Global Animal Welfare and Compliance Comparative Medicine Worldwide Research and Development Eastern Point Road, MS 8220-4327 Groton, CT 06340 860-441-8377 (w) 860-625-7467 (cell) gloria.j.gaito@pfizer.com