REMS: A Standardized Approach to Risk Management

Date: September 22, 2010
Pages: 42
Price:
US$ 395.00
Publisher: FirstWord
Report type: Strategic Report
Delivery: E-mail Delivery (PDF)
ID: R559B29A99DEN
Leaflet:

Download PDF Leaflet

REMS: A Standardized Approach to Risk Management
Risk Evaluation and Mitigation Strategies. Until recently, the Federal Drug Administration’s REMS program impacted drugs that would not have been otherwise approved due to their risks.

The hurdles, costs and additional barriers in getting a drug to market were faced by few. Yet increasingly, risk mitigation is becoming a key feature in the American pharmaceutical landscape.

Where the FDA once focused on individual high-risk products, it has now turned its attention to drug-class REMS, such as those affecting long-acting opioids. And criticism is mounting. Increasingly, stakeholders want more input into the development of the REMS process, and greater transparency in REMS decisions.

And while increased REMS requirements will undoubtedly affect drug companies, pharmacists, health plans, physicians and their patients, there are benefits, from improved promotional opportunities and value propositions to drug life extension.

In REMS: A Standardized Approach to Risk Management, FirstWord examines how the industry faces increasing regulatory hurdles through the implementation—and expansion—of federal risk management initiatives. The sharply-written report addresses the drawbacks and benefits to drug-class REMS, as well as insights into how such programs have affected drug roll-out and marketing. Based on the most current information, interviews and news, the report offers the pharmaceutical industry a much-needed roadmap to how REMS will affect business.

The report offers insights into:
  • The benefits and drawbacks to REMS
  • The implications to the industry of drug-class REMS

KEY FEATURES
  • Complete background on the historical and regulatory development of REMS
  • Breakdown of the challenges and negative impacts associated with REMS
  • Examination of the case for and against class-wide REMS
  • Chart outlining best practices and recommendations from recent stakeholder meetings

CASE STUDIES EXAMINED IN THE REPORT
  • Biogen Idec’s TOUCH program
  • Cephalon’s COVERS program
  • Amgen’s NEXUS program
  • Celgene’s STEPS program
EXECUTIVE SUMMARY

BACKGROUND

REMS versus RiskMAPs
From RiskMAPs to REMS
REMS components

CHALLENGES ASSOCIATED WITH REMS

Impact on timelines
Impact on drug sponsors
Impact on primary care physicians
Impact on revenue potential

OPPORTUNITIES WITH REMS

Improving the promotional mix
Improving the value proposition
Extending the life of a drug

UNINTENDED CONSEQUENCES OF REMS

Effect on generic drugs

CLASS-WIDE REMS

Examples of class-wide REMS

EXTENDED-RELEASE OPIOID DRUG PRODUCTS

Industry response
Public consultations
Onsolis REMS
Future outlook

CONCLUSION

Best practices and recommendations

INDEX
Skip to top


Ask Your Question

REMS: A Standardized Approach to Risk Management
Company name*:
Contact person*:
Phone/fax*:
Email*:
Request invoice
Your enquiry:
Please click on a Check Box below to confirm you are not a robot: