Fda Cms Pro Industry Initiatives

FDA/CMS “Pro-Industry” Initiatives: Good or Bad for Industry? April 12, 2011 Edward E. Berger, Ph.D. Larchmont Strategic Advisors

Defining the problem Life sciences enterprises are subject to well defined regulation by FDA and CMS Both agencies have recently implemented a series of “pro-industry” initiatives Industry dissatisfaction with and distrust of the agencies is nonetheless running high Need to understand the counterproductive impact of agency efforts

FDA “pro-innovation” initiatives have disappointed many in industry Fast track, accelerated approvals and priority review for pharmaceuticals Least burdensome principles for devices Adaptive clinical trials and Bayesian statistical analysis General commitments on review times

FDA drive toward improved responsiveness continues Medical Device Innovation Initiative (Feb ‘11) Voluntary third-party certification for med device test centers to promote rapid improvement …. Create a core curriculum …to train a new generation of innovators Use more non-U.S. data Formal horizon scanning to predict new technology directions Improved 510k process

CMS recent policy initiatives Humanitarian Device Exemption coverage Coverage for clinical trials Coverage with evidence development Restrictions defined by patient attributes or provider qualifications/experience Enrollment in clinical study (of specified design) or mandated registry

Industry doubts about the CMS initiatives CED imposes continuing costs CED determinations are impermanent Coverage limited to subsets of patients is a mixed blessing Clinical trials coverage comes with compliance issues Medicare coverage for drugs may be getting more difficult (Provenge)

Two major recent joint FDA/CMS initiatives MOU of June 23, 2010 Process and standards for interagency information sharing Parallel review of new technologies Federal Register, September 17, 2010) CMS coverage review simultaneous with FDA marketing review Emphatically ambivalent industry response

Memorandum of Understanding 6/23/2010 The Food and Drug Administration (FDA) and the Centers for Medicare & Medicaid Services (CMS), both as part of the Department of Health and Human Services, and hereinafter also referred to as "Federal partners," agree to work together to promote initiatives related to the review and use of FDA-regulated drugs, biologics, medical devices, and foods, including dietary supplements , as defined by the Federal Food, Drug and Cosmetic Act (see 21 U.S.C. 321) and the Public Health Service Act. (See 42 U.S.C. 262).

Purpose of the MOU … to promote collaboration and enhance knowledge and efficiency by providing for the sharing of information and expertise between the Federal partners. The goals of the collaboration are to explore ways to: Further enhance information sharing efforts through more efficient and robust inter-agency activities. Promote efficient utilization of tools and expertise for product analysis, validation and risk identification. Build infrastructure and processes that meet the common needs for evaluating the safety, efficacy, utilization, coverage, payment, and clinical benefit of drugs, biologics and medical devices

Substance of the MOU Single contact person in each agency as contact for information sharing requests Requests honored except for good reason Procedures to prevent inappropriate disclosure of trade secrets or proprietary information No change in legal or regulatory powers or responsibilities of either agency

Some CMS/FDA data sharing has always occurred CMS staff attend FDA panel meetings Companies have long been able to authorize FDA releasing data to CMS CMS typically requests such authorization during informational meetings Industry has often rejected the requests Worries about proprietary information Reluctance to cede control of information

Purpose of parallel review To improve patient access to safe and effective medical innovations Shorten the time from market clearance to Medicare coverage Create investment incentives for VCs and companies by shortening the time to ROI

There are precedents for parallel review Human Recombinant Erythropoietin (EPO) Initial FDA approval June 1, 1989 Medicare coverage policy and reimbursement negotiated prior to FDA approval Drug eluting stents (DES) In Aug. 2002, Medicare announced new DES DRGs, with associated payment levels, effective April 1, 2003 Coordinated to FDA approval timeline

What EPO and DESs had in common High visibility during product development and clinical trials High expectation of clinical value Clinicians and patient advocates Well organized and very well funded advocacy programs _____________ No level playing field for parallel review

New initiatives level the field CMS is legally committed to the same protection of proprietary data as FDA Substantial transparency in selection of products for parallel review FDA has selected a small company product to pilot its innovation initiative DARPA-funded prosthetic arm

Serious impediments to successful implementation Agency budget limitations Ability to attract and retain competent staff Lack of stable leadership at FDA and CMS Congressional mixed messages Demanding perfect safety assurance while criticizing pace of approvals Playing politics with key appointees (Berwick) See budget limitations (above)

Edward E. Berger, Ph.D. Larchmont Strategic Advisors 2400 Beacon St., #203 Chestnut Hill, MA 02467 Tel: 617-645-8452 Email: [email_address] Thank You

Fda Cms Pro Industry Initiatives

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