Comments of Knowledge Ecology International Regarding “Purple Book Enhancement; Establishment of a Public Docket; Request for Comments” (FDA-2020-N-0437)

May 4, 2020

Comments of Knowledge Ecology International Regarding “Purple Book Enhancement; Establishment of a Public Docket; Request for Comments” (FDA-2020-N-0437)

Knowledge Ecology International (KEI) provides the following comments regarding the Food and Drug Administration [FDA]’s Purple Book Enhancement. Our comments address Question No. 4: “Are there other types of information or functionalities that would be useful to include in the Purple Book database?” We recommend that the FDA adds the following information and make this information searchable in the publicly available database.

  1. The patent landscape of each biologic;
  2. The enrollment and costs of each clinical trial cited in the medical review by the FDA for the approval of the product, as of the date of the FDA action;
  3. The amount of direct funding, tax credits or other subsidies provided by governments or charities toward clinical trials associated with FDA approval of the biologic;
  4. Market authorizations in foreign countries, if any, for the same biologic;
  5. The number of units sold for every presentation, and the net revenue for such sales, in the United States, and in foreign markets.
  6. Meta data on any licenses on patents, know-how, data or biologic resources that were required for make, import or sell and biologic, including but not limited to the names of the parties, a description of the technology, materials or data licensed, the field of use, geography areas, the period of exclusivity and the economic considerations.

These measures are designed in part to comply with the norms set out in WHA72.8, adopted in May 28, 2019, by the World Health Assembly, titled “improving the transparency of markets for medicines, vaccines, and other health products”

The public is entitled to much greater transparency of markets for medical inventions, including in particular, the biologics in the FDA Purble Books. Prices for biologic products and services are often excessive and place enormous strains on household budgets and health systems, and lead to barriers for access. To reform pricing and incentives systems, the public needs to have as much access to information about the value chain for the development and distribution of medicines as do companies and investors. The lack of transparency today is a major public policy failure, and evidence of excessive political influence by drug companies.

James Love, Knowledge Ecology International
1621 Connecticut Avenue NW, Suite 500, Washington, DC 20009

James Love

James Love is the Director of Knowledge Ecology International. Previously, he was an economist for the Center for Study of Responsive Law where he also directed the Consumer Project on Technology and the Taxpayer Assets Project, Senior Economist for the Frank Russell Corporation, and held lecturer positions at Rutgers and Princeton Universities. His KEI webpage is