Fostering Innovation in OTC Drug Development

Transcription

1 Fostering Innovation in OTC Drug Development Theresa Michele, M.D. Division of Nonprescription Drug Products Office of New Drugs Center for Drug Evaluation and Research Food and Drug Administration (FDA) May 15, Outline Sunscreen Innovation Act (SIA) What the Act does NOT do What the Act does (statutory requirements) FDA actions since SIA enactment OTC monograph reform Nonprescription Safe Use Regulatory Expansion (NSURE) 2 1

2 Sunscreen Innovation Act P.L Enacted November 26, 2014 Goal to provide an alternative process for review of safety and effectiveness of nonprescription sunscreen active ingredients and for other purposes (nonsunscreen TEAs) 6-year sunset provision for timelines for new requests but not for the new sunscreen TEA order process 3 Time and Extent Application (TEA) Process Before SIA TEA Eligible? Yes No Ineligibility Letter Federal Register notice No Timelines Data submitted & evaluated Proposed Rule In some cases, letter to data submitters and docket Comments Final Rule 4 2

3 What SIA Does NOT Do Guarantee timelines to put new sunscreen ingredients on the market Timelines for FDA actions are triggered by industry s submission of required data Change Generally Recognized as Safe and Effective (GRASE) standards Change FDA s scientific review Change rulemaking process for monographs or the overall monograph system Provide additional FDA resources for monograph, TEA, or SIA review 5 What the SIA Does Statutory Requirements Sunscreens New process for review of active ingredients Defined review timelines Administrative orders Requires publication of guidances Requires rulemaking Nonsunscreen Provides additional framework for pending TEAs: administrative orders or rulemaking Requires rulemaking to establish timelines Government Accountability Office (GAO) and FDA reports to Congress 6 3

4 Sunscreen Review Process Changes rulemaking process to orders Sunscreen orders Applies only to nonprescription sunscreen active ingredients Mandatory FDA review timelines Format and content requirements for new requests FDA can refuse to file a deficient application Provides for public notice and comment Advisory committees may be convened during review Ingredients FDA finds GRASE can be marketed under terms of Final Orders 7 SIA Sunscreen Guidances Four FDA Guidances for Industry Application format and content, criteria for refuse to file Safety and efficacy data requirements Withdrawal of request Use of advisory committees Timelines Draft guidances must publish within 1 year [November 26, 2015] Final guidances must publish within 2 years [November 26, 2016] 8 4

5 SIA Sunscreen Rulemakings Final regulations on sunscreen monograph must be finalized within 5 years [November 26, 2019] If the regulations do not include SPF and dosage forms, FDA must report to Congress on the reasons why not and include a plan to address in rulemaking 21 CFR Sunscreen Rulemaking 9 Nonsunscreen TEA Process Pending Applications Sponsor to request framework within 180 days of enactment and include a preferred review process [May 25, 2015] SIA order process without filing requirements Rulemaking process without filing requirements SIA order process with filing requirements Rulemaking process with filing requirements FDA to provide timelines for review by 1 year [November 26, 2015] 10 5

6 Nonsunscreen Rulemakings Proposed Rule on framework for review of nonsunscreen TEAs issue by 18 months [May 26, 2016] 60 day comment period Final Rule by 27 months [February 26, 2017] Rules must include timelines for review 21 CFR Nonsunscreen TEA Framework 11 Progress since SIA Proposed orders issued for all 8 eligible sunscreen ingredients January 6, 2015 (6 ingredients with prior feedback letters) February 24, 2015 (2 ingredients) Meetings with industry 2 different sponsors, 4 ingredients Stakeholder meeting Transparency information/ucm htm roductsandtobacco/cder/ucm htm 12 6

7 Recommendations for Monograph Meeting Requests Submit meeting requests to the ingredient docket with a copy to the Division of Nonprescription Drug Products Follow guidelines for formal meetings Guidance for Industry: Formal Meetings Between FDA and Sponsors or Applicants RegulatoryInformation/Guidances/UCM pdf Meetings granted as Division resources and timing of rulemakings allow Meetings are public; logistics will be posted to the docket FDA minutes will be posted to the docket 13 Monograph Reform Part 15 Hearing: March 25 and 26, 2014 Proposed potential reform areas Addressing safety changes Finalizing tentative final monographs (TFMs) Keeping up with rapidly changing science 14 7

8 Monograph Challenges Submissions may come from multiple sources without a structured format Single comment may address more than one issue; all entered into one docket Multiple layers of review required DNDP OND CDER OCC/OP/Commissioner HHS [other HHS agencies] OMB [other Federal agencies] Rulemaking includes elements not generally required for NDA drug approvals e.g. Paperwork Reduction Act, economic analysis 15 SIA and Monograph Reform Scope of SIA is limited overall monograph reform still needed Some aspects of SIA may be helpful for monograph reform Format and content of data packages Administrative order process FDA is committed to moving forward with reform and continuing dialogue with stakeholders Progress may be delayed due to resource constraints and demands of SIA and antiseptics consent decree 16 8

9 Future of Nonprescription Products What should the nonprescription drug market look like in 20 years? Can the delivery of information for correct self selection and use be improved? How can technology impact on self selection and use and expand the availability of certain drug products? Can healthcare providers such as pharmacists or technology interventions have a greater role? 17 OTC Drug Products OTC drug products generally have these characteristics: Can be adequately labeled such that The consumer can self-diagnose, self-treat, and self-manage the condition being treated No health practitioner is needed for the safe and effective use of the product Drug has low potential for misuse and abuse Safety margin is such that the benefits of OTC availability outweigh the risks 18 9

10 Current Limitations of OTC Switch Purchasing decision based on information in Drug Facts label and on principal display panel Other conditions for marketing are not considered for determining switch Rx and OTC not permitted at same time; same indication, population, dose, etc. Image found at 19 Nonprescription Safe Use Regulatory Expansion (NSURE) Alleviate the undertreatment of common conditions or diseases by using innovative technologies or other conditions of safe use to expand which drug products can be considered nonprescription Explore regulatory approaches that allow for the expansion of the nonprescription drug market Communicate the NSURE initiative to interested stakeholders and public started with Public Hearing March 2012 Explore and further develop a practical regulatory framework for the NSURE concept 20 10

11 Misconceptions Misconception New paradigm will reduce or eliminate doctors visits. Consumers will incorrectly select drug products for use. FDA is considering the creation of a third class of drugs. Clarification Intent of the program is to reach those who are not currently seeing a health care provider, not to stop those who do go to the doctor from going. Conditions of safe use would be tested to ensure that they help patients select products correctly. Drugs will remain either prescription or non prescription. 21 Misconceptions Misconception FDA is granting pharmacists prescribing power. Every prescription drug product will eventually be OTC. Clarification NSURE cannot grant pharmacists prescribing power. Licensing of, and authority over the practice of medicine, pharmacy and other health professionals, including prescriptive authority, is generally granted and controlled by the States. The approval of a drug product as non prescription with a condition of safe use will be product specific and is intended to undergo FDA s rigorous drug approval process

12 Communication and Outreach Expert workshops through a cooperative agreement with the Engelberg Center for Health Care Reform at Brookings Nov 08, 2012 Workshop: Nonprescription Medications with Conditions of Safe Use as a Novel Solution for Undertreated Diseases or Conditions May 09, 2013 Workshop: Innovative Technologies and Nonprescription Medications: Addressing Undertreated Diseases and Conditions through Technology Enabled Self-Care November 4, 2013 Workshop: Exploring Implications of the Nonprescription Drug Safe Use Regulatory Expansion (NSURE) Initiative on Reimbursement and Access Presentations and meetings with stakeholders and other Federal Agencies 23 Contact Information For questions regarding OTC drugs Division of Nonprescription Drug Products Food and Drug Administration New Hampshire Ave. Building 22, Room 5491 Silver Spring, MD Division Phone: Please any questions concerning NSURE to the Office of Medical Policy at: CDER-OMP-DMPP@fda.hhs.gov 24 12

13 Additional Information Monograph SIA information/ucm htm Meetings er/ucm htm Status of rulemakings ver-the-counterotcdrugs/statusofotcrulemakings/default.htm NSURE