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

James Love james.love at keionline.org
Mon May 4 17:44:46 PDT 2020


May 4, 2020

Comments of Knowledge Ecology International Regarding “Purple Book
Enhancement; Establishment of a Public Docket; Request for Comments”

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

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

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