Congress Set to Extend Monopoly Patents for Cipro and Other Top-Selling Drugs

Nov. 9, 2001

Congress Set to Extend Monopoly Patents for Cipro and Other
Top-Selling Drugs

Drug Industry Lobbying Effort Will Let Cipro?s Maker Reap $358 Million; Drug Companies Would Make $29.6 Billion More for Testing Drug Safety in Children

WASHINGTON, D.C. ? While the Bush administration claimed to negotiate a tough deal for a government stockpile of Cipro, a drug industry lobbying campaign has pushed Congress to quietly pass legislation that will give a six-month monopoly patent extension to Cipro and more than 100 other drugs, according to a new Public Citizen study.

The patent extension legislation, which passed the Senate on Oct. 18 and will be voted on by the House of Representatives as early Monday, Nov.12, is based on this premise: If drug companies test their products for safety in children, they should receive a six-month patent extension.

The costs of the safety and efficacy tests sought by pediatricians, children?s advocates and the U.S. Food and Drug Administration (FDA) is estimated at $727 million, according to Public Citizen?s report, Patently Offensive. The reward, in terms of added sales, to patent-holding drug companies is $29.6 billion, according to the FDA ? a return 40 times the industry?s projected investment in pediatric tests. Cipro?s maker, Bayer, would garner an extra $358 million in sales due to the anthrax-fighting drug?s patent extension, according to the report.

“The drug industry has put on a cynical PR front about its patriotic efforts to fight bioterrorism,” said Frank Clemente, director of Public Citizen?s Congress Watch. “Meanwhile, it has refused to sacrifice a penny ? not even for children?s health ? in its uncontrolled drive for monopoly patent extensions and sky-high profits.”

Public Citizen believes that pediatric tests should be required as part of the FDA?s drug approval process with no special financial incentive. The federal government doesn?t give drug companies monopoly patent extensions to test their products in other consumer populations such as women or African-Americans. Public Citizen?s report shows that:

  • Bayer, the exclusive manufacturer of Cipro, lobbied for the patent-extension legislation and spent $3.7 million on campaign contributions and lobbying since 1999. A six-month patent extension for Cipro would pay for all of Bayer?s contributions and lobbying since 1999 in just two days.
  • Children?s groups have played a crucial role in helping to pass the patent extension legislation. The Coalition for Children?s Health, which touts itself as the “leading coalition in Washington on children?s health policy,” is financially supported by the drug industry, chaired by a former drug industry lobbyist, and composed of several groups financially supported by the drug industry.
  • Three of the four chief sponsors of the patent legislation ranked in the top 10 in the Senate and House respectively in campaign receipts from the drug industry in recent years. Senate sponsors Chris Dodd (D-Conn.) and Mike DeWine (R-Ohio) ranked third and seventh, respectively, among the Senate?s leading recipients of drug industry contributions from 1990-2000. House co-sponsor Rep. Anna Eshoo (D-Calif.) ranked sixth among the House?s leading recipients of drug industry contributions since 1992 (when Eshoo was first elected).
  • The drug industry employed lobbyists with close connections to key lawmakers and congressional committees. For instance, Steve Ricchetti, deputy chief of staff to former President Clinton and a former Democratic Senatorial Campaign Committee executive director, played an important part lobbying for the bill with Senate Democrats, who were largely mute on the issue. Merck ? which has 12 drugs eligible for the pediatric patent extension ? hired as a lobbyist the former health care aide to Eshoo. Shortly afterwards, Eshoo became the chief Democratic sponsor of the patent extension bill when the original co-sponsor sought to eliminate the monopoly patent extension.
  • In efforts to trim the enormous profits gained from pediatric patent extension legislation ? estimated at $592 million a year, according to the FDA ? House Democrats offered amendments during an Energy and Commerce Committee markup that would have paid the drug companies twice the amount they spent on pediatric tests or would have cut the length of patent extensions to three months for blockbuster drugs. The drug industry rejected those proposals. Members voting against amendments that would have saved consumers billions of dollars received nearly three times as much in drug industry contributions as those representatives who voted for the pro-consumer amendments.

“It?s outrageous that Congress feels the need to bribe drug companies to do what they should be required to do, and that is test the safety and efficacy of drugs for our children,” said Clemente. “The drug industry has claimed recently that it is patriotic and unselfish. Well, it blew a golden opportunity to help the nation?s children and consumers on this monopoly patent extension bill.”

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