BIO Comments on FDA docket Standards for Future Opioid Analgesic Approvals and Incentives for New Therapeutics to Treat Pain and Addiction
The Biotechnology Innovation Organization (BIO) appreciates the opportunity to provide input and recommendations to the FDA on the docket titled Standards for Future Opioid Analgesic Approvals and Incentives for New Therapeutics to Treat Pain and Addiction. BIO is the world’s largest trade association representing biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations. BIO’s members develop medical products and technologies to treat patients afflicted with serious diseases, to delay the onset of these diseases, or to prevent them in the first place.
November 18, 2019
Re: Docket No. FDA-2019-N-2514: Standards for Future Opioid Analgesic Approvals and Incentives for New Therapeutics to Treat Pain and Addiction.
Dear Sir/Madam:
The Biotechnology Innovation Organization (BIO) appreciates the opportunity to provide input and recommendations to the FDA on the docket titled Standards for Future Opioid Analgesic Approvals and Incentives for New Therapeutics to Treat Pain and Addiction. BIO is the world’s largest trade association representing biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations. BIO’s members develop medical products and technologies to treat patients afflicted with serious diseases, to delay the onset of these diseases, or to prevent them in the first place.
BIO and our member companies are committed to taking all appropriate measures in conjunction with the FDA, for assuring safety, especially redressing serious problems with safety, abuse, and addiction relating to extant opioid analgesics, and pursuing innovation to reduce or eliminate these risks attendant to this class of therapy.
BIO agrees with the Agency that opioid analgesics are clinically significant therapies that nevertheless bear meaningful risks of addiction, overdose, and death. These risks are serious challenges that must be managed effectively by Sponsors, providers, and patients, including through compliance with the risk evaluation and mitigation strategy (REMS) required of opioid analgesic drugs intended for inpatient and outpatient use.
BIO also believes that risks associated with opioid therapies can be surmounted through further innovation on safe and effective analgesics with lower risks, thus the focus of BIO’s comments included in this letter will specifically address question 9 posed by the FDA in the docket, incentives needed to better support and encourage development of therapeutics intended to treat pain or addiction.
