Mary Ruwart, Libertarian for President

by Dr. Mary Ruwart

FDA doesn't need more bureaucrats

The Food and Drug Administration's proposal to hire 1,300 more employees is a cure worse than the disease, said Dr. Mary Ruwart, Libertarian candidate for president.

"As a research scientist for 19 years, I know government regulation is the primary reason healthcare costs are so high in the first place," Dr. Ruwart said. "They add at least 80 percent to the costs of new, life-saving drugs."

Dr. Ruwart worked for the Upjohn Company in Michigan from 1976 to 1995 developing new therapies for a variety of disease, including AIDS. She now lives in the Austin area and devotes her time to writing and providing consulting services to nutraceutical and pharmaceutical companies.

In announcing the hiring program, FDA Commissioner John Dyer direly warned, "Each month there is a delay in bringing critical staff on board impairs the agencies ability to fulfill its mission."

"Just the opposite is true." Dr. Ruwart contends. "As the FDA has grown larger, and its regulations more detailed, the cost and time needed to approve a new drug have increased dramatically. It now takes 15 years to get a new drug approved. It cost nearly $1 billion (capitalized) to bring the average new drug to market."

"In the meantime, people die. Since 1962, almost 5 million people have died who could have been helped by a drug in development," she asserted. "And that is just the tip of the iceberg."

For example, the FDA's tardy approval of propranolol, the first beta blocker for heart disease, needlessly killed an estimated 30,000 Americans during the three years it was available in Europe, but not the U.S.. "The FDA probably killed more people, by delaying this single drug, than it saved during its entire existence. Licensing laws are a cure worse than the disease."

"If a loved one were dying, we'd never snatch lifesaving drugs from their grasp," Dr. Ruwart said. "Yet we unwittingly do just that with FDA consumer protection regulations.”

On behalf of terminally ill cancer patients, the Abigail Alliance recently sued the FDA on the grounds that dying individuals have a Constitutional right to buy experimental medicines before FDA approval. When the courts ruled against the Abigail Alliance, the case was sent to the Supreme Court, which refused to hear it. Consequently, dying Americans have no Constitutional right to the medications that might save them. Bureaucrats in the FDA hold our lives in their hands.
Consequently, cancer and AIDS victims often turn to black market chemists, who do a brisk business selling new, but unapproved, drugs to dying patients.
Before the FDA became so pervasive, the American Medical Association and Consumers Research tested new drugs themselves and gave good ones their "Seal of Approval."

"Certification by professional pharmaceutical organizations, or even the FDA itself, would be the more compassionate approach and won't t make criminals of people fighting for their lives," Dr. Ruwart proposed.

These organizations could certify drugs with ratings like “untested,” “safe in animal testing,” or “effective in humans.” "With the help of trusted medical professionals, consumers could make an informed choice that took into account their personal situation," Dr. Ruwart explained.

Actually, the FDA does no drug testing at all, but simply mandates that drug companies do it, and even charges them for the approval processDr. Ruwart said third-party testing by multiple certifying organizations would be much more objective. "Greedy corporations intent on defrauding consumers wouldn't be able to falsify data, as they are sometimes accused of doing today," she said. "Medications without any certification data at all would likely be shunned by both physicians and patients, effectively putting bogus companies out of business. Underwriters’ Laboratories perform the same function for electrical appliances and have an admirable safety record."

"Draconian licensing and regulation schemes have increased the cost, reduced the availability, and damaged the quality of health care in America," Dr. Ruwart concluded. "We're literally protecting ourselves to death. It's time to unleash the power of the market and usher in an era of access to quality---and affordable---health care for all."