Washington – Gov. Dannel P. Malloy and other elected officials lobbied the Obama administration for a provision in the Trans-Pacific Partnership trade pact that would protect pharmaceutical companies making some of the most cutting-edge and expensive drugs against competitors who want to make cheaper, generic versions of those medicines.
The Trans-Pacific Partnership is being negotiated privately. Members of Congress have complained about difficulties they have in determining what the nations involved are agreeing to, and the only release to the public about anything in the agreement was done by WikiLeaks.
Malloy spokesman Devon Puglia said the governor is not ready to weigh in on the TPP. Several members of the Connecticut congressional delegation already have said they would oppose it, and Rep. Rosa DeLauro, D-3rd District, is a leader of the opposition.
“We have not seen the contents of the agreement and cannot comment on something we haven’t seen,” Puglia said.
The governor did weigh in on at least one hot-button issue in the proposed trade pact. In 2011, Malloy came down on the side of the U.S. pharmaceutical industry on the issue of how long some of their most expensive drugs should be protected under the TPP, putting the governor at odds with consumer and health advocates, including the AARP, on the issue.
The provision concerns the fate of biological drugs, made from living organisms and used to treat a growing number of diseases that now include cancer, AIDS, rheumatoid arthritis and diabetes.
Popular biologic drugs include Remicade and Enbrel, which fight rheumatoid arthritis and Crohns’s disease.
Under U.S. law the U.S. pharmaceutical industry has 12 years of “data exclusivity,” the period during which generic versions of the drugs — known as biosimilars — that are manufactured using data generated by the original maker, cannot be approved for sale by the FDA .
Malloy and a group of elected officials that includes other governors and key members of Congress have asked Obama to insist U.S. trading partners under the TPP adopt the U.S. standard — which is longer than that in Canada and Mexico and most countries in Europe and Asia.
“Among your priorities for these negotiations, we ask that you include very strong intellectual property rights provisions, consistent with U.S. law, for protecting the investments of our innovative, intellectual property-intensives sectors, such as biopharmaceuticals,” said a letter to Obama signed by Malloy and six other governors.
The letter also said the biopharmaceutical sector supports more than 3 million U.S. jobs.
An aide to the governor said that Malloy, in signing the letter, wanted U.S. law — whatever the time period it provides for protections — to be the controlling time period in any agreement.
Connecticut has a substantial drug industry presence, and Malloy is committed to encouraging bioscience as a jobs driver for the future, pushing, among other things, to attract the Jackson labs, a facility in Farmington that specializes in genetic research.
Former Maryland Gov. Martin O’Malley and former Massachusetts Gov. Deval Patrick where among those who signed the letter. Dozens of members of Congress, including the entire Massachusetts delegation to the U.S. House of Representatives, have also lobbied the president on behalf of the industry.
“In 2011 and 2012, members of both Houses of Congress and governors from 11 states, have repeatedly expressed bipartisan support for the extension of this 12 year standard to the TPP,” the Pharmaceutical Research and Manufacturers of America said in a statement. “These leaders have shown that they recognize the critical role that regulatory data protection plays in allowing innovative pharmaceutical companies to cover the extensive costs involved in bringing their products to market.”
The 11 Pacific Rim nations that would join the United States in the TPP have periods of exclusivity that range from zero to 12 years. The exclusivity period in Japan and Canada is eight years.
President Obama, the AARP and others want that period of exclusivity to be seven years, or less, in the United States.
So does the generic drug industry.
“By delaying the entry of biosimilars, the TPP would be setting a terrible precedent in one of the highest-stakes areas of medicine,” said Ralph Neas, president of the Generic Pharmaceutical Association.
Neas said Obama has asked Congress in his last four budgets to reduce the exclusivity of biological drugs to seven years.
He also said no trade agreement the United States signs should “undermine” Congress’s ability to reduce the period of exclusivity or “help the U.S. healthcare system save billions of dollars.”
Mark Grayson, spokesman for the Pharmaceutical Research and Manufacturers of America, or PhARMA, said he’s grateful for the help of Malloy and the other elected officials.
“What we believe is that 12 years of data protection is optimal to make sure the newest kinds of medicines get to market,” Grayson said.
For years, members of Congress have introduced bills that would pare back the exclusivity period for biological drugs.
“They’ve been defeated over and over again,” said Grayson, who believes the issue is settled.
But the AARP and others don’t think so. They are still hoping Congress cuts the time biological drugs are protected and are lobbying the administration to drop the demand for biological drug exclusivity in the TPP.
“With annual prices that can reach $400,000, the high cost of biologic drugs not only has negative effects on consumers and patients, but also on health care payers, including programs like Medicare and Medicaid, as well as children in developing countries who are most vulnerable to dying from vaccine-preventable diseases,” AARP lobbyist Nancy LeaMond and Sophie Delaunay, executive director of Doctors Without Borders/Médecins Sans Frontières wrote in a recent op-ed.
LeaMond and Delaunay said the Obama administration had made it clear that it disapproves of these protections by repeatedly proposing in its federal budgets to reduce the market exclusivity period, so “why is the U.S. pushing for even more monopoly protections in the TPP? ”
Because of the 12-year exclusivity period, there is not a single biosimilar in the U.S. market, even as they are available in other countries. There are seven biosimilars on the market in Japan, for instance.
In January a Food and Drug Administration panel recommended the approval of the first biosimilar drug, Zarzio, which helps the body make white blood cells and is used by patients undergoing chemotherapy for cancer. Zarzio, available in 40 countries, is a close copy of a drug called Neupogen that costs more than $300 a dose.
But the FDA is still working on a regulatory path that would allow biologics like Zarzio to be prescribed in the United States.