Elsevier Business Intelligence announces the publication
of a new Special Report:

FDA’s REMS Program:
How It Can Hurt – or HELP – your Drug
Guidance for a smooth approval process
& working successfully with the new requirements

Contains recent insight and analysis from"The Pink Sheet" and The RPM Report

FDA's new power to require Risk Evaluation and Mitigation Strategies (REMS) as part of a drug’s approval could be the most important change to FDA’s authority in the last 20 years. The questions for drug sponsors are abundant: How often are REMS provisions required for new drugs? What could trigger a REMS requirement for my drug? What types of REMS provisions are typically required? At what stage of drug development should I start planning for REMS? Will my drug be delayed while I negotiate REMS requirements with FDA? Are there any commercial opportunities I can turn to my advantage from having a REMS?

In this Special Report, you get answers to all these questions and many more, from our analysis of the most important REMS programs to date, to the specific regulatory and commercial experiences of the first companies to go through the REMS process.

This detailed 43-page report includes critical information for regulatory, legal, R&D, and business development executives, and anyone who works for or with biopharma companies to meet the new REMS requirements.

Prepared by Elsevier Business Intelligence’s expert analysts, this Special Report highlights:

• How REMS is delaying drug approvals and what you can do to prepare for negotiations with FDA
  
• Why the regulatory and commercial prospects of some drugs actually benefit from the new REMS requirements
• What healthcare professionals are saying about REMS, and whether restrictions and additional paperwork might discourage prescriptions for REMS drugs
  
• How REMS could impact generic and follow-on approvals
• Why FDA seems to be imposing more stringent REMS restrictions in the second year of the program

… and much more

Time, money and REMS

For sponsors, being subject to a REMS means focusing additional dollars, time and resources to abiding by it. Creating and implementing a REMS program can cost anywhere from several hundred thousand dollars for a basic MedGuide to millions to develop a restricted access program. According to one assessment, developing a REMS program and awaiting FDA response has added between two and nine months to review times.

Opportunities for service providers?

What's bad news for drug sponsors could become a new source of revenue for service providers to the industry: REMS has been a boon to consultants, lawyers, market research firms, software developers and marketing support firms whom pharmaceutical companies are increasingly turning to for help when it comes to developing a REMS.

The silver lining?

This report doesn't stop with reporting the bad news. Instead, our analysts have observed that there are numerous unlooked-for benefits to REMS. Sponsors who have already mastered the difficult process seem to have a smoother road the next time around. Then there are strict  postmarketing requirements that often include practices, such as DTC marketing, that FDA has previously frowned on, so REMS could actually lend these activities new legitimacy and the stamp of FDA's approval.

These are just some of the issues and actionable guidance included in this report. And it could only be delivered by Elsevier Business Intelligence, provider of the most in-depth, accurate, expert business intelligence in health care today.