Life Science Compliance Update

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June 12, 2013

FDA Building a Prescription Drug and Marketing Database

Government Watching Us
Over the last several years, we have written extensively about the potential implications that the Physician Payments Sunshine Act will have on physicians and the life sciences industry. One of the greatest implications is that numerous government and private entities will be able to use the publicly posted payment data to "data mine" for certain trends and information to identify potentially fraudulent behavior or medically unnecessary services.

Living up to our predictions, although somewhat indirectly related to the Sunshine Act, the Food and Drug Administration's (FDA) Office of Criminal Investigations (OCI) recently issued a solicitation notice on the Federal Business Opportunities (FBO) website indicating that the agency is looking for an outside party to put together a prescription drug data and marketing database. Below is a summary of what FDA is looking for.

What is most interesting about this proposal is that the type of database FDA is seeking to establish is the very kind of database that researcher, federal and state prosecutors, HHS-OIG, and CMS will be using collaboratively to identify patterns of fraudulent or suspect behavior. Coupled with the payment data from the Physician Payment Sunshine Act and Medicare Part D prescription data, federal and state officials will have a truly powerful resource once these databases are up and running.

FDA Off-Label Marketing Database Solicitation

As background, FDA's OCI was formed in 1992 by the Commissioner, with the urging of Congress, in response to concerns of increased criminal violations of the Federal Food, Drug, and Cosmetic Act (FDCA) and related acts.  The mission of the OCI is to investigate suspected criminal violations of the FDCA; the Federal Anti-Tampering Act (FATA); and other statutes including applicable Title 18 violations; and to collect evidence to support successful prospective actions through the federal or state court systems, as appropriate.

In the middle of FY10, OCI established their Pharmaceutical Fraud Program (PFP) with funding from the Centers for Medicare and Medicaid Services (CMS) to investigate health care fraud. A vital part of OCI's PFP mission is to protect the public health by assuring pharmaceutical companies are not off-label marketing their prescription drugs and that the information they provide to the public through their marketing is truthful and accurately communicated.

To fulfill this mission, OCI requires the availability of timely access to current and historical data for analysis and forecasting of trends relating to FDA approved pharmaceuticals and biologics based upon their distribution, prescribed usage and advertising and promotional expenditures.

Based on this background, FDA stated that the objectives of the proposed contract are to access data representing sales and expenditures by pharmaceutical companies on promotional and advertising strategies at a national level in the United States and obtain analytical support services to assist with further developing investigative leads related to law enforcement sensitive evidentiary data collection. The data will be real-time, immediate, direct, multi-user, with desktop access to currently existing, commercially available, to current and historical data.

Data Requirements

FDA stated that the data collected will include prescription drug data describing national estimates of expenditures by pharmaceutical companies including national estimates of product sampling and promotional expenditures data as well as the content and message of pharmaceutical detailing and advertising campaigns. The overall data characteristics provided shall include:

  • number of products included in the sample;
  • number of hospital pharmacies in the sample;
  • the number of professional journals in the sample;
  • number of consumer journals in the sample (if applicable);
  • number of physicians and distribution of physician specialties in both outpatient and inpatient settings;
  • number of manufacturers in the sample;
  • type of advertising media included in the sample; and
  • census and geographic regions (e.g., individual states) in the sample.

Basic data elements must be available to OCI at the product level and product package level. These data shall also be available in monthly and annual increments for all prescription drugs and biologics with at least six (6) years of historical data from the start date of the contract. The promotion-specific basic data elements must include (but are not limited to):

  • monthly summary of promotional dollar expenditures for manufactures and pharmaceutical products;
  • physician office-based promotional expenses (includes cost of promotional contacts, on-site educational presentations, telephone calls, and service visits);
  • hospital-based promotional expenses (included cost of promotional contacts to hospital-based physicians and pharmacists, on-site educational presentations, and drug fairs);
  • professional journal advertising (including medical, dental, hospital, and drug trade journals);
  • retail value of samples provided to office-based physicians;
  • retail value of samples provided to hospitals (desired, but not required);
  • DTC advertising (e.g., TV, radio, newspaper, magazine, and outdoor advertising);
  • additional DTC media (e.g., mailings to consumers such as coupons and cost of internet advertising) (desired, but not required); and
  • expenses for promotional presentations (e.g., dinner meetings, exhibit booths at conferences, etc.) (desired, but not required).

The basic data elements for the office-based and hospital-based contact reports will include (but are not limited to):

  • information to include the total contacts to office-based physicians and hospital-based physicians and pharmacists, including specialty physicians;
  • the details of the message provided to physicians (first time detail, use of product, and product message discussed);
  • the ability to search by key phrase in message provided to physician;
  • the ability to search by geographic area of the country for specific messaging;
  • the details of number of minutes spent on calls (desired, but not required); and
  • dollars spent by specialty on contacts (desired, but not required).

The basic data elements for manufacturer and pharmaceutical product sampling reports will include (but are not limited to):

  • information to include form, strength, and volume of product samples provided to office-based physicians;
  • hospital sampling information (desired, but not required); and
  • information to include how the sample was provided (e.g., via in-person presentation, left during service visit, sent by mail) (desired, but not required).

The basic data elements for both professional DTC journal advertising campaigns will include, if available:

  • report by manufacturer and pharmaceutical product;
  • search by journal ad name;
  • search by date;
  • search by therapeutic class;
  • search by campaign message (e.g., "better than," "first in new class," etc.); and
  • Includes a picture of the entire ad (with brief summary) with enough resolution to see fine print, and includes dollar expenditures by manufacturer, therapeutic class, and pharmaceutical product.

OCI is looking for access to continuous data resources on health care practitioner prescribing practices including, but not limited to drug treatment patterns, patient demographics and indications for treatment in the outpatient setting throughout the length of the contract.

 

FDA intends to use this data, included information on sales updated on a monthly and yearly basis, to analyze and describe national patterns of expenditures by pharmaceutical companies on prescription drug promotion through the use of projection or other appropriate methodologies that are scientifically sound and transparent to OCI personnel.

FDA seeks to have an online database that will provide OCI personnel with the ability to use these data in support of new and ongoing investigative case work that will include the content and message of pharmaceutical detailing and advertising campaigns, This unique service requirement include:

  • Online display of electronic images of current drug journal advisements that allow a user to visualize the actual size, color, and content of the advertisements related to a specific FDA regulated product.
  • Healthcare professional verbatim that analyzes physician's perceptions of pharmaceutical sales representatives detail messages in relation to intended uses of the FDA regulated products; key messages driving brand performance; and historical product launches.

FDA is also seeking a contractor that will "provide OCI with clinical compliance and analytic tools specific to the following which is directly supports law enforcement related matters:

  • Waste, Fraud and Abuse expertise
  • Claims data review
  • Payer benchmarking
  • Health cost/benefit analysis
  • Pharmacy subject matter expertise

For now, FDA's still looking for a partner for the activity, which it says will span four years if all goes well. A final contract is slated to be awarded on 1 July 2013. Under some options, the data collection could go from 2014 through 2018.

 

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