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. Last Updated: 07/27/2016

Russia to Free Up Import of U.S. Drugs

Embracing U.S. scientific standards, Russia has decided to allow near-automatic importation of hundreds of thousands of prescription and over-the-counter drugs made by American companies, the Clinton administration has announced.


The agreement, hammered out in more than a dozen meetings between U.S. and Russian health authorities during the past year, effectively makes the U.S. Food and Drug Administration the major drug regulatory body for Russia.


Representatives of foreign drug companies in Moscow had a mixed reaction to the move Thursday. While some said that it would significantly speed the emergence of new drugs on the Russian market, others expected that the country's bureaucracy would still present a formidable obstacle.


U.S. officials said the decision, made public Wednesday, should enhance public health in a country whose quality of health care has deteriorated recently, along with its overall economy. It also could boost long-term profits for U.S. pharmaceutical companies, they said.


"We're not talking just about new, breakthrough drugs but penicillin, vaccines, insulin, drugs for hypertension, for polio, for diphtheria. This permits them to get even the basic, old-line workhorses," said Mary Pendergast, a lawyer and deputy Food and Drug Administration commissioner who negotiated the memorandum of understanding between the two countries.


Eduard Malayan, senior counselor at the Russian Embassy in Washington, concurred, saying: "This agreement will benefit Russia not only in the short term by providing drugs to our people, but also in the long term by allowing businesses to engage more actively in this field in Russia."


In the agreement, completed this week, the Russian Health Ministry said that it will eliminate virtually all barriers to the importation of drugs and biological products that have been approved by the FDA.


Felix Kishner, a sales manager with the Moscow office of U.S. pharmaceutical company Merck Sharp & Dohme, welcomed the move, saying that basic drugs to treat viral infections and high blood pressure had sometimes taken years to register in Russia.


"This is a step in the right direction," he said.


But Andrei Kazanov, registration manager at Bristol-Myers in Moscow, expressed pessimism that the memorandum could be implemented in practice.


"I used to work for the Health Ministry," he said. "These days they can charge for additional tests, which means they will do their best to prolong registration."


Russia imports about $350 million worth of drugs annually -- more than 70 percent of its needs. But U.S. pharmaceutical companies account for only $7 million of that, according to FDA Commissioner David A. Kessler.


He said the agreement means "potentially very large" financial gains for U.S. drug-makers. The United States does not import drugs from Russia.


Jean-Pierre Lalain, general manager with France's Servier in Moscow, worried that the memorandum, which takes effect immediately, would give U.S. pharmaceutical firms an unfair advantage on the Russian market.


"I hope it is the first step and in the future Russia will sign similar memorandums with European countries," he said.


As part of the deal, the Russian ministry will no longer require U.S. companies to conduct clinical trials in Russia ofdrugs approved in the United States.


The ministry also will limit its review of such drugs to a 90-day period. Until now, there was no limit to the review period and U.S. manufacturers often were required to prepare voluminous scientific data in Russian.


"This is the best kind of international cooperation," said


Donna Shalala, secretary of the Department of Health and Human Services. "It can quickly bring some of the world's safest and most effective drugs to millions to relieve their suffering and improve the quality of their lives."The three-year, renewable agreement also calls for "prompt exchange of information on removal of drugs and biological products from the market or restrictions on their use."


(LAT, MT, Washington Post)