As part of a partial response to FOIA request, USTR has provided KEI with copies of 13 letters sent by members of Congress, from July 27, 2011 to August 8, 2013, on the topic of biologic drug test data provisions in the TPP negotiation. We had obtained several but not all of these letters earlier from a variety of sources, including from PhRMA’s web page — where some had been proudly displayed. (See link below).
Were there letters on the other side? Yes, three. (see below).
With the FOIA request, we have also obtained the responses to the letters.
Most of the 13 letters include multiple signatures from Members of Congress from both parties, such as the 37 US Senators signing a September 12, 2011 letter circulated by Senators Orrin Hatch and John Kerry, or the 40 members of Congress signing a letter to President Obama on July 27, 2011.
The letters were provided to KEI as part of a FOIA request we filed last year. We received only two letters from 2013, including a March 22, 2013 letter from Senators Baucus and Hatch to acting USTR Marantis, and an August 8, 2013 letter from Hakeem Jeffries and ten other members of the House of Representatives to the recently confirmed USTR Michael Froman. All of the other letters were from 2011 to 2012, and were letters sent either to then USTR Ron Kirk or to President Obama, and cc’d to Ron Kirk.
PhRMA had managed the letters so some were organized by state delegations, such as the letter from Delaware Senators Carper and Coons, the letter from Texas Senators Hutchison and Cornyn, the letter from Washington State Senators Murray and Cantwell, the letter from Oklahoma Senators Inhofe and Coburn, and the letter signed by eight members of the House of Representatives representing Massachusetts.
It is doubtful that we have obtained a complete set of letters from Congress on this topic, but this collection is already an impressive illustration of PhRMA’s power with both political parties.
Note that all consumer groups working on these issues, including AARP, Public Citizen, PIRG, KEI, and several labor unions and State legislators have opposed the 12 year term for biologic test data, and the President’s own budget has long called for a rollback in the US law from 12 years to 7 years.
Those supporting an obligation in the TPP for 12 years of exclusive rights in test data want to make it nearly impossible to reduce the term in the US domestic legislation. On this issue, like many others these days, PhRMA has support from the right, center and left of both parties. None of the Senators or Representatives pushing for the 12 years term for test data rights have expressed any interest in safeguards for the predictable (and frequent) cases where a company selling a biologic drug charges too much money (pick any standard for what constitutes an excessive or unreasonable price), as if drug prices are a non-issue for the United States health care system, and our only interest is in promoting higher prices around the world. This is what unlimited private funding of campaigns leads to — government for those who fund the campaigns.
Note: KEI’s September 5, 2012 blog on this topic reports on some but not all of these letters.
See also: Members of Congress and Governors backing PhRMA/BIO, calling for 12 years data protection for biologic drugs in TPP. September 5, 2012. /node/1544
Here are the 13 letters expressing support for 12 years of protection for biologics:
- July 27, 2011. Letter from 40 members of the United States Congress urging President Obama to support current U.S. law on biologics, which provides for 12 years of protection, during TPP negotiations.
- September 12, 2011. Letter from 37 members of the United States Senate to Ambassador Ron Kirk, urging for a 12-year term of regulatory data protection for biologics consistent with U.S. law. USTR response here.
- September 12, 2011. Letter from Senator Mark Udall and Senator Michael F. Bennet to Ambassador Ron Kirk, stressing the importance of proposing a high standard of intellectual property rights for biologics, which is consistent with the 12 years of exclusivity under U.S. law. USTR response to Udall here and to Bennet here.
- May 3, 2012. Letter from Senator Tom Carper and Senator Christopher A. Coons urging President Obama to ensure high intellectual property standards in any TPP agreement, including a 12-year data protection for biologics. USTR response here.
- May 4, 2012. Letter from Senator Kay Hutchison and Senator John Cornyn to Ambassador Ron Kirk, stressing the importance of proposing intellectual property protection for biologic drugs that reflects the 12 years of exclusivity consistent with U.S. law. USTR response here.
- May 11, 2012. Letter from Senator Robert Menendez to President Obama, emphasizing the importance of securing robust intellectual property rights for biologics, including 12 years of data protection as found in U.S. law. USTR response here.
- July 12, 2012. Letter from Senator Patty Murray and Maria Cantwell to President Obama, stressing the importance of robust intellectual property rights for biologics, including 12 years of data protection as found in U.S. law. USTR response here.
- July 13, 2012. Letter from 8 members of the House of Representatives from Massachusetts to President Obama, calling for 12 years of exclusive rights in biological drug test data. USTR response here.
- August 6, 2012. Letter from Senator Claire McCaskill to President Obama, supporting 12 years of exclusivity for biological medical products. USTR response here.
- September 10, 2012, Letter from Senators James Inhofe and Tom Coburn, the two Republican Senators from Oklahoma, supporting 12 years of exclusive rights for biological drug drug test data. USTR response to Inhofe here and to Coburn here.
- November 29, 2012. Letter from Senators Toomey and Casey. USTR response to Casey here and to Toomey here.
- March 22, 2013. Letter from Senators Baucus and Hatch to acting USTR Marantis.
- August 8, 2013. Letter from 11 members of the United States Congress urging Ambassador Michael Froman to ensure the TPP trade agreement contains a high standard of protection for intellectual property, specifically robust measures to protect copyrights, patents, trademarks and trade secrets.
Three letters that take positions in opposition to PhRMA on the test data issue.
There were two letters that, while not specifically referring to biologic test data, called for flexibility on the test data issue. There was one letter, from Representative Waxman and six other members of Congress, that specifically opposed 12 years of exclusive rights in biologics test data, while endorsing 7 years of exclusive rights.
- August 4, 2011. Letter from Congressman Waxman and six others recommending that the United States refrain from negotiating a 12 year biologics exclusivity provision.
- December 1, 2011. Letter from Senator Sanders expressing strong objections to the reversal of U.S. trade policy during negotiations on the TPP Agreement with respect to flexibility on test data.
- September 8, 2011. Letter from Congressman John Lewis and four others expressing support of move flexible test data protections