ParagonRx® builds appropriate use programs for medications and medical devices to mitigate risks and optimize use

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  • Are You Attending the FDLI’s Important REMS Conference in Washington?
    Guest Blogger Roger Morris, The LondonBritain Company Having worked in communications in the pharmaceutical industry for more than 25 years, I continue to be amazed at how even strong competitors remain so open to sharing information and experiences.  Perhaps it’s the academic nature of pharmaceutical research that filters out to everyone else in the business, but the [...]
News: Feb 5, 2010
Allergan v. FDA: Where Does Disseminating Safety Information End and Promotion Begin?

In the Fall of 2009, the drugmaker Allergan made waves when it sued the FDA alleging that the ban on off-label promotion was chilling its “First Amendment right to share truthful medical information with physicians about how to safely use Botox off-label [to treat muscle spasticity] to achieve a benefit while minimizing risk of serious adverse events.”  Allergan was back in the news last week when the LA Times reported that trial was set to begin in a case brought against Allergan by the mother of Kristen Spears, a seven-year-old girl with cerebral palsy who died after being injected with Botox to treat muscle spasticity in her legs.

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inVentiv Health Acquires ParagonRx

inVentiv Health

inVentiv Health, Inc., a leading provider of commercialization services to the global healthcare industries, announced it has acquired ParagonRx, a leading consulting company specializing in pharmaceutical risk management and optimizing medication use. The addition of ParagonRx will position inVentiv as the leading provider of comprehensive, fully-integrated REMS (Risk Evaluation & Mitigation Strategy) and risk management solutions, ranging from strategic consulting and program design to implementation coordination, project tracking and assessment. The acquisition was completed on December 31, 2009.

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Five Possible Barriers to Product Adoption

  1. The drug does not fit well into an existing patient care process resulting in increased work load.
  2. Severe known risks of an existing drug are easier to manage than unknown risks of a new drug.
  3. The definition of an “appropriate” patient may be different from one physician to another.
  4. Actual barriers to adoption may be different than the ones verbalized by physicians.
  5. The physician is not always the one making the treatment decision.  The nurse and/or other allied health professionals play a major influential role.

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Five Reasons to Consider Risk Mitigation in Early Development

  1. Forecasts will have more accurate “top box”
  2. Survey design can factor in appropriate patient groups
  3. Avoid regulatory approval delays
  4. Sales reps can overcome potential objections at launch
  5. Product can reach peak sooner
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PDUFA Date Coming Up?

Be prepared and avoid approval delays with:

  • A robust evidence base for risk assessment and mitigation
  • Contingency plans to meet regulatory requirements
  • A  fully-documented risk mitigation program that will also increase comfort with prescribing
  • The infrastructure for program implementation at launch and ongoing assessment
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Ten Things to Consider When Developing a REMS

Ten of the most important considerations to take into account when developing a REMS:

  1. Patient Safety First
  2. Create Options
  3. Co-design with Stakeholders
  4. Use Science-Based Approaches
    5. more...

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Will the FDA require a REMS for your new compound?

Check this qualitative index of the likelihood that FDA may require a REMS for a specific development compound as part of the NDA submission.  The presence of any attribute increases the probability of a REMS requirement...

  • New mechanism of action
  • Theoretical risk based on new MOA
  • Small clinical study population
  • more...

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