PPTA Letter to Stakeholders re: European Data Program

Dear PPTA Stakeholders:

PPTA is pleased to announce the addition of public reporting of monthly distribution data for plasma protein therapies to its Web site, www.pptaglobal.org.This data is intended to provide patients and other stakeholders, as well as manufacturers and regulators, with information regarding the availability of these critical, often life-sustaining, therapies.

Although, thankfully, there have been no recent shortages of plasma protein therapies, the issue of drug shortages is once again in the headlines and has drawn the attention of European regulators. In November 2012, for example, the European Medicines Agency (EMA) published a Reflection Paper that described medicinal product shortages as “public health crises” – crises that are particularly challenging to address in the context of biologics, where there are “greater regulatory hurdles” and “concerns about the equivalence of product from different manufacturing sites.”2 EMA noted that any effective response would require “clear and transparent communication” by manufacturers.3

PPTA subsequently participated in EMA’s October 2013 workshop on drug shortages.4 At the workshop, PPTA staff described the Association’s existing, North American data program5 and, in response to EMA’s challenge, pledged to implement a similar program in Europe. PPTA’s presentation was well-received by the workshop participants and strongly supported by EMA staff.

Today’s reporting of European distribution data on PPTA’s website is the first step because PPTA is starting by reporting data on the Recombinant Factor VIII product category. This data will be reported as a monthly, aggregate figure constituting total distribution within a particular country. The data will be reported with a 3-month lag, meaning that the July 2013 data currently on the Web site is the November update. The data for August will be posted in December. The data will be reported in graphical format, with one line showing monthly distribution and a second line showing a 12-month rolling average (samples attached).

PPTA expects to be able to expand the program to encompass all major categories of plasma protein therapies, rather than just Recombinant Factor VIII, by January 2014 for those countries when two conditions are met:

1. All manufacturers (members and non-members) are providing data to the program
2. The total number of manufacturers distributing therapies is at least 3.

At that time, the product categories included in the European Data Program (in addition to Recombinant Factor VIII) will be: Albumin ≤ 5%, Albumin 20% - 25%, Intravenous Immune Globulin, Subcutaneous & Intra-Muscular Immune Globulin, Plasma-Derived Factor VIII, and Plasma-Derived Factor IX.

PPTA supports EMA’s call for a voluntary, proactive industry response to the issue of drug shortages, and believes that its European Data Program constitutes a major step in the right direction. PPTA staff is planning to meet with stakeholders to explain both the mechanics and benefits of the program in greater detail. 

In the meantime, if you have any questions regarding the Data Program or would like to discuss further, please do not hesitate to contact Association staff.

Sincerely,

Santoni
Bruno Santoni
Executive Director
PPTA Europe


 

ESG13004 Sample Germany RFVIII - July 2013 ESG13004 Sample Spain RFVIII - July 2013

 


[1] The specific Web site content regarding the European Data Program is available at:
http://www.pptaglobal.org/safety-quality/european-programs/european-distribution-data.
[2] Reflection paper on medicinal product supply shortages caused by manufacturing/ Good Manufacturing Practice Compliance problems, European Medicines Agency, 22 November 2012, EMA/590745/2012, Patient Health Protection, at 2, 4.
[3] Reflection paper on medicinal product supply shortages caused by manufacturing/ Good Manufacturing Practice Compliance problems, European Medicines Agency, 22 November 2012, EMA/590745/2012, Patient Health Protection, at 3, 4.
[4] Details of the workshop are available on EMA’s Web site at: http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/events/2013/10/event_detail_000796.jsp&mid=WC0b01ac058004d5c3.
[5] PPTA’s North American Data Program was developed and implemented at the recommendation of U.S. regulators. See Dep’t of Health and Human Services (HHS) Advisory Cmte. on Blood Safety and Availability, Blood Safety Recommendations – April 1998 (May 8, 1998), available at http://www.hhs.gov/ash/bloodsafety/advisorycommittee/recommendations/resapr98.html. It continues to receive strong support for the Food and Drug Administration (FDA). See HHS and FDA, Permanent Discontinuance or Interruption in Manufacturing Certain Drug or Biological Products, 78 Fed. Reg. 65,910 (Nov. 4, 2013) (FDA “recognizes and greatly appreciates the efforts by PPTA to provide plasma product supply information to FDA and the public”).

 


 

 

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