This is a report from the FDA on 2011 new molecular entities (NMEs) approvals, through June 6, 2011. The total number of FDA approvals during that same period was 150. So far, 16 NMEs have been approved in five months, a sharp increase in approvals over the same period 2010.

6 NMEs NDAs were considered priorities
8 NDAs that were considered standard approvals
2 BLA (biologic products) that were not classified.

• NMEs were 10.7 percent of all approvals.
• The NME priority NDAs were 4 percent of FDA approvals.

On July 1, 2010, William Yue, the Senior Counsel, Office of the Chief Counsel for International Commerce at the US Department of Commerce, wrote to Joel Blank and John Cobau about the ACTA negotiations. John Cobau was the Chief Counsel for International Commerce at the U.S. Department of Commerce, and Joel Blank was International Attorney-Advisor at US Department of Commerce.

A redacted version of this email was the only document released to KEI as part of a larger FOIA request concerning the Department of Commerce role in the ACTA negotiations. A copy is available here:

Six NGOs, including Knowledge Ecology International (KEI), Medecins Sans Frontieres (MSF), Oxfam, Third World Network (TWN), Universities Allied for Essential Medicines (UAEM), and Young Professionals Chronic Disease Network (YP-CDN), recently submitted recommendations to Member States to control non-communicable diseases (NCDs) in low- and middle-income countries in advance of the Moscow Ministerial conference.

A PDF of the joint statement with logos of the groups is available here:
http://keionline.org/sites/default/files/ncd-6healthngos-moscow.pdf

On April 1, 2011, Marietje SCHAAKE and Christian ENGSTRÖM submitted a parliamentary question on the appointment of Maria Martin-Part as the new head of unit for copy

On March 22, 2011, the British Medical Journal (BMJ) published the following guest editorial about the EU/India Free Trade Agreement negotiations.

The following groups and individuals have written to Anand Grover, the Special Rapporteur for the United Nations on the right of everyone to the enjoyment of the highest attainable standard of health, to lodge a complaint about the Trans Pacific Partnership (TPP). The TPP is a regional free trade agreement being negotiated by the governments of Brunei, Chile, New Zealand, Singapore, Australia, Malaysia, Peru, Vietnam and the United States.

KEI has obtained the February 10, 2011 US government draft of the intellectual property chapter of the Trans-Pacific Partnership Agreement (TPP).

http://keionline.org/sites/default/files/tpp-10feb2011-us-text-ipr-chapter.pdf

David Hammerstein is a former Member of the European Parliament from Spain. He now works for the Trans-Atlantic Consumer Dialogue (TACD). Among other things, he is an advocate for a new WIPO copyright treaty for persons who are blind or have other disabilities. The following is an interview with David, carried out from March 3 to March 6 by email.

On January 20, 2011, 9 civil society organizations sent a letter to the WHO Executive Board registering an objection to the selection of Dr. Paul Herrling of Novartis to the WHO Consultative Expert Working Group on Research and Development: Financing and Coordination. The groups signing the letter were:

• CIDEPRO
• Déclaration de Berne - Berne Declaration
• HAI Europe
• HAI Global
• Health GAP (Global Access Project)

WHO has kindly made available its conflict of interest guidelines. Apparently they are not available from the public web page. Attached are two documents:

• Conflict of Interest Guidelines and Procedures
• Declaration of Interests for WHO Experts

A few of the many interesting provisions follow:

I. MEANING OF "CONFLICT OF INTEREST"

The following is an August 10, 2010 letter written by Alberto Cerda Silva, a Research Associate of Knowledge Ecology International, to Felipe Calderón Hinojosa, Presidente Constitucional de los Estados Unidos Mexicanos, regarding the position of the Mexican government in the ACTA negotiations.

On April 28, TACD will be holding a meeting from 9 am to 3 pm at the U.S. Department of Commerce, in Washington, DC, to discuss the proposed Anti-Counterfeiting Trade Agreement (ACTA).

Below are asks from the 2010 PhRMA submission to the USTR Special 301 list on the topic of drug pricing and reimbursement decisions, and described as 'Market Access Barriers.' In its assertions, PhRMA attack countries for government price negotiations, making use of reference pricing, the insufficient involvement of pharmaceutical companies in setting government pricing policies and the composition of drug formularies, among other things.

CHINA

On July 28, 2006, Jeffrey Kindler replaced Hank McKinnell as CEO of Pfizer. That day the Pfizer stock price closed at $26.11. With the stock trading today at a little more than $17, it would seem that shareholders have lost a significant amount of their investment. Nonetheless, Kindler is doing well.

Billy Tauzin announced today that he will be stepping down as President and CEO of the Pharmaceutical Research and Manufacturers of America (PhRMA) at the end of June 2010.

PhRMA's 990 Tax Return Form, Schedule J-1 shows the amount Tauzin was compensated in 2008:

Base compensation: $2,055,445
Bonus & incentive compensation: $692,875
Other reportable compensation: $159,412
Deferred compensation: $1,556,960
Nontaxable benefits: $11,465

Total: $4,476,157