Bio & Pharmaceuticals

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Updates From PhRMA

11 Jan, 2011

By: Trade & Industry Development
PhRMA Lauds Breakthrough in the Korea-U.S. Free Trade Agreement Talks

Pharmaceutical Research and Manufacturers of America (PhRMA) President and CEO John Castellani released the following statement on the breakthrough in the talks on the Korea-U.S. Free Trade agreement:

“PhRMA welcomes the progress made on the Korea-U.S. Free Trade Agreement. This agreement recognizes the 60 years of partnership between our two countries and the important national security ties that we share.

“PhRMA has long viewed the Korea-U.S. Free Trade Agreement as a terrific opportunity for Korean patients to access biopharmaceutical medicines produced in the United States. With rising living standards and increasingly sophisticated access to information, Korean patients, like patients everywhere, want access to the most advanced medical treatments.

“We believe this Agreement, particularly the transparency and intellectual property provisions, represents a 21st century standard that should be a model for other agreements.

“Korea is an important market for the U.S. research-based pharmaceutical companies, a country where we currently enjoy a trade surplus. This agreement will contribute directly to increased U.S. exports and the expansion of highly skilled, well paying jobs here.

“PhRMA looks forward to the ratification of the Agreement by Congress in the next year.”

Sino-Phirda and PhRMA Sign Joint Cooperation Agreement
Following a two day conference in Washington, DC, the China Pharmaceutical Industry Research and Development Association (SINO-PhIRDA) and the Pharmaceutical Research and Manufacturers of America (PhRMA) signed a cooperation framework that embodies the intent of the multi-national pharmaceutical companies and Chinese pharmaceutical companies to continue a regular dialogue that will facilitate the two organizations working together.

“Everyone is impressed by the dedication and commitment of Chinese biopharmaceutical research companies to create new and better medicines for the global market. At PhRMA we all look forward to the time when we, hopefully, will count many of the companies here today as PhRMA member companies,” said John J. Castellani, President and CEO of PhRMA.

The conference highlighted topics such as intellectual property rights and other incentives for innovation, ensuring safety and efficacy and the challenges and opportunities of simultaneous global development of pharmaceuticals. Participants at the conference heard speakers from the U.S. Department of State, the Patent and Trademark Office, the International Trade Administration as well as the Food and Drug Administration. Chinese and U.S. industry leaders also addressed the conference.

Mr. Castellani further stated, “The better ties between our two countries, along with better ties between PhRMA member companies and SINO-PhIRDA and the Chinese biopharmaceutical research industry will help us better address the scientific, medical, regulatory and other challenges we face and help us, together, make better medicines available to the world’s patients who need and who hope for new cures and treatments.”

PhRMA Statement Regarding FDA’s Drug Safety Oversight
Pharmaceutical Research and Manufacturers of America (PhRMA) Senior Vice President Ken Johnson issued the following statement today regarding the safety of drug ingredients derived from abroad:

“The lifeline of America’s biopharmaceutical research companies is the safety and integrity of the products they develop. Brand-name pharmaceutical companies make tremendous investments in quality control systems and take extensive measures to help protect patient safety and to help prevent adulterated ingredients from entering into America’s prescription drug supply.

“In addition, drug manufacturing for the U.S. market – regardless of where it occurs – is regulated under Good Manufacturing Practices (GMP) by the Food and Drug Administration (FDA). These GMP requirements help to assure the safety, quality and purity of drug ingredients that are used in the U.S. prescription drug supply.

“The U.S. regulatory system for prescription drugs is the toughest and safest in the world. PhRMA and its member companies have been working with Congressional leaders over the last several years on ideas for making further improvements to the safety of our drug supply. We look forward to reviewing U.S. Sen. Michael Bennet’s bill closely as part of that continuing effort.”

PhRMA Statement Supporting Enhanced Transparency
The Pharmaceutical Research and Manufacturers of America (PhRMA) issued the following statement regarding efforts to enhance transparency:

“PhRMA and its member companies have a longstanding commitment to the ethical conduct of clinical trials and to increasing transparency by reporting more information about clinical trials.

“We are always looking for ways to enhance our voluntary industry codes and, to this end, supported a joint position statement in June with the International Federation of Pharmaceutical Manufacturers & Associations to enhance publication of clinical research. The joint statement calls for publication of summaries of all Phase III clinical trials and all clinical trials of significant medical importance in peer-reviewed journals.

“PhRMA’s commitment to enhanced transparency of clinical research is in addition to our member companies’ unanimous support of PhRMA’s recently revised Principles on Conduct of Clinical Trials and Communication of Clinical Trial Results, which call for registration and online publication of summaries of all clinical trials in patients for approved medicines. What’s more, PhRMA’s Clinical Trial Principles also call for our member companies to disclose summaries of all clinical trials in patients for investigational medicines whose development programs have been discontinued.

“It is our hope that the additional transparency of PhRMA’s member companies will benefit patients and healthcare professionals. PhRMA has also supported continued development of the federal clinical trial database, ClinicalTrials.gov.

“The study, published by the ‘Annals of Internal Medicine,’ demonstrates one more way that patients and the public health can benefit from increased transparency: The study would not have been possible without the large volume of information about ongoing and completed industry-sponsored clinical trials provided through ClinicalTrials.gov and supported by PhRMA and its member companies.

“While our review of the study continues, it is important to note that the authors acknowledge that industry-funded trials tended to be for later stages in the lengthy drug development process. As the authors note, ‘Later-phase trials may be more likely to have positive outcomes, because there is more certainty about the drug’s efficacy and safety at this advanced stage in the drug-development cycle.’

“Developing a new medicine is costly, time-consuming and the odds of success are quite low. At the earliest stage of discovery, researchers closely analyze up to 10,000 compounds of interest. By the time clinical tests occur in humans, more than 10 years later, promising therapies have been winnowed from the thousands to single digits.

“PhRMA companies lead the world in the search for new cures. Our member companies invested an estimated $45.8 billion in 2009 alone to discover and to develop new medicines.”

The Pharmaceutical Research and Manufacturers of America (PhRMA) represents the country’s leading pharmaceutical research and biotechnology companies, which are devoted to inventing medicines that allow patients to live longer, healthier and more productive lives. PhRMA companies are leading the way in the search for new cures. PhRMA members alone invested an estimated $45.8 billion in 2009 in discovering and developing new medicines. Industry-wide research and investment reached a record $65.3 billion in 2009.

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