Created to Help You Survive                                                                                   July 2011

YourDocs was created to help you survive an environment where wrongful prosecution not only is possible but, has also been reported.  As you might imagine, it happens as a complete surprise to the innocent victims.  

 

A client hired HBA YourDocs following their unfortunate experience with wrongful prosecution.  They wanted to maintain their profession without paranoia that at any moment disaster could strike.  Such disasters may result from rules that are sometimes less than clear and well defined. (Article below)

 

The assignment to HBA was to develop fully compliant processes that would always present the client as fundamentally compliant with the full set of governmental rules, regulations, and statutory provisions.

 

This solution was really quite simple -- full web based visibility to regulators and client reporting at all times.  This is discreetly accomplished with complete client control over the terms, reporting, and conditions of access regulators or anyone else must electronically sign to review the knowledge base of the client. - YourDocs, it works.

 

For your free demonstration of how easily you may live peaceably in a sometimes unpredictable and threatening environment visit hba.yourdocs.net or Call Keri Kimler (800) 883-8705 or submit your request here.

 

As you may recall, many of our previous newsletters addressed related topics.  You may review our January, February, March, May, and June Newsletters (Here) 

 

- YourDocs Team

 
Seven Major Pharmaceutical Companies File Citizen Petition Seeking FDA Guidelines Regarding Off-Label Information

The controversy, concerns and risks are ever present in the headlines. This month is no exception with the news of a Citizen Petition submitted on behalf of seven medical product companies asking the Commissioner of Food and Drugs to clarify FDA regulations and policies with respect to manufacturer dissemination of information relating to new uses of marketed drugs and medical devices.

 

As a general best practice, once manufacturers have discerned what they believe is the correct interpretation of the FDA's letters, other agency materials, and publicly available papers from settled criminal investigations (i.e. government press releases, information, statements of factual bases for pleas, and related documents), they develop internal guidelines and policies governing the dissemination of labeled information and train their sales representatives, field medical personnel, and other relevant employees on the information that may appropriately be shared about their products.

 

In the face of uncertainty, manufacturers may develop policies that do not align with the government's expectations. When the agency will be able to offer comprehensive guidance is an unknown. Regardless of any petition, YourDocs may help you comfortably operate in today's ambiguous environment.      

 

Are you engaging in any of the following activities?

  1. Interactions with Formulary Committees, Payors, and Similar Entities
    1. Providing information to formulary review personnel and/or requesting physicians/departments 
    2. Providing information to managed care organizations
    3. Providing information to providers for use with third-party payors in order to obtain coverage of and reimbursement for products or services.
  1. Responding to unsolicited requests
  2. Communicating information about:
    1. Product uses
    2. Investigational products pre-approval
    3. Off-label uses of approved or cleared products to providers for use with payors to address prior authorization or other utilization control issues

If the answer is "YES" to even one of the above, we hope you will call us to schedule a confidential demonstration.

 

There is simply no other option right now and this petition is another reminder of the limbo state many manufacturers reside today.

 

(Read More)
 
There is no reason to wait.

Yourdocs© unique subscription cloud service was created to meet the challenges and risks confronting today's health industry sales and marketing managers and those responsible for implementing regulatory compliance.

 

YourDocs© provides a framework for monitoring point-of-entry through gateways created by your organization giving full control of how information is accessed, when, by whom and for how long.  The Yourdocs© gateway maintains full security and recording of access and dissemination of company documents and web links.     

 

Subscribers to the YourDocs service control who has access to information, how long access is provided to requester, what information requester has access to, and how long requester has access to individual documents and or links.  

 

Examples of requirements that may be managed with YourDocs:

 

·    Medical Communications

·    Hospital Approvals

·    Distributor Relations

·    Development & Training

·    Committee Meetings

·    Invoicing

·    Product Order, Delivery and Transfer

·    Inventory Control

·    Continued Education

·    Product Marketing

·    Events

·    Education

·    Current Catalogs

·    Price Lists

·    Literature Files

·    Contract Agreements

·    Supporting Documentation

·    Product Information Use

·    In-Service & Training Records

·    Policies and Procedures Manuals

·    Presentation/Resources

 

Monitor and Generate Real Time Reports for Compliance Audits:

 

   1) Promotional Activity Reporting

   2) Corporate Integrity Agreement Implementation & Compliance (Available to 3rd Party Firms) 

   3) Credentialing Product Specifications to Hospitals 

   4) Branding and Labeling to Remain Firmly Within FDA Guidelines

   5) Field Sales and Management Training Programs /  Proof of Competency

   6) Interactions with Consultants and Speakers