Regulatory and Legal


Informed Consents and Patient Labeling that “Patients Can Understand”

Patient education

The message is clear and simple for the pharmaceutical industry

 “Speak the language of the patient if you want to help protect your product from lawsuits. Help patients understand how to take the medication safely.”

 

Studies show that up to 87% of Informed Consent Documents cannot be understood by patients.  This puts the patient’s life in danger and makes pharmaceutical companies very liable.  It also leads to patient nonadherence during clinical trials and potentially toxic doses.

The consumer media is filled with articles describing the consumer realization that they are not being given the information they need to know about their prescription medications in language they can understand.  One of the best examples was the Merck/Vioxx trial in 2005.  After the trial concluded, the jurors  complained that “labels and communications from drug companies were incomprehensible.” (Wall Street Journal, August 22, 2005 )  One juror demanded:

“Give us in layman’s terms what the drug can do to us.  Let us decide.”

Other jurors complained that they could not understand the scientific evidence being presented and that it sailed right over their heads:

“We didn’t know what the heck they were talking about.”

The company’s general counsel responded:

“We are learning as we go along about how best to present evidence to juries composed of lay people.”

This lawsuit illustrated the importance of communicating the right balance of risks and benefits in clear language that consumers can understand.

Here’s How We Can Help

Our expertise is translating complicated medical and regulatory terminology into language that patients will understand.

We have years of experience working with Regulatory and Legal teams in pharmaceutical companies to help ensure that patients will understand the patient information they are given.  Our experience ranges from helping patients understand how to participate in a clinical trial to how to manage a medication or a medical device.  We go one step farther and incorporate behavior modification techniques appropriate for the specific patient audience so that patients will not only understand the patient information but will be motivated to take charge and not drop out of therapy prematurely.

The Consumer Health team has worked closely with the Regulatory divisions of pharmaceutical companies and FDA for years.  We have a very successful track record with speedy FDA approvals.  We have been able to help our clients get their products to market 6 months earlier than expected as well as repeatedly increased sales by 50% by developing patient education materials that meet the needs of patients.

Here’s how we can assist you or your clients in the area of patient education as it relates to Regulatory and Legal requirements:

  • Work with your regulatory and legal teams to make Informed Consent Documents understandable to patients
  • Develop patient education materials and patient adherence strategies from Phase III clinical trials and product launches
  • Develop patient education for REMS and side effect management materials
  • Develop FDA-approved patient labeling to be submitted as part of the NDA
  • Develop “how to use” patient instructions for medical devices, prescription and OTC drugs
  • Patient engagement and patient advocacy support

Click here for more information about Patient Labeling and Informed Consent.