- The Washington Times - Thursday, March 9, 2006

The head of the Food and Drug Administration told the pharmaceutical industry this week that the federal health agency is working to improve the approval process for personalized medicines.

FDA Commissioner Dr. Andrew von Eschenbach said the agency, which supervises prescription drug sales and marketing, last month started an initiative with two other federal health agencies to speed up the delivery of specialized tests and treatments.

Techniques to identify diseases on a molecular level can help physicians diagnose patients based on their genetic makeup instead of relying on factors like family health history, Dr. von Eschenbach said.

“For most Americans, the concept of personalized medicines is still somewhat visionary. But it’s a complex subject we must advance,” he told a group of biotechnology and pharmaceutical representatives Monday.

While use of personalized medicines is in its “infancy stage” in the U.S. health care system, Dr. von Eschenbach said the medications are gaining more acceptance from doctors and need a quicker system to get to patients.

But “rapid does not mean a reckless [approval] process,” Dr. von Eschenbach said.

The FDA has been criticized over the past few years as popular drugs were pulled from the market because of safety concerns, recalls of heart defibrillators and pacemakers increased, and controversy grew over wider access to emergency contraception.

The speech came one week after the agency issued new rules that accelerate the development and approval process for seasonal and pandemic flu vaccines.

Patients use ER for headaches

While most Americans use over-the-counter medications, 7.5 million U.S. adults in an average year bought prescription drugs or visited the doctor’s office or emergency room to treat their headaches, according to recently released government data.

Those prescriptions and visits, which were sought from 2002 to 2003, cost insurers and patients a total average of $4.3 billion each year, according to the Agency for Healthcare Research and Quality, which compiled and released the data this week.

Statisticians for the federal health agency said they found “little difference,” after adjusting for inflation, from 1997 to 2003 in the number of Americans seeking medical treatments for headaches or the overall cost of that care.

Gaithersburg company advances trials

GenVec Inc., a Gaithersburg biopharmaceutical company, on Tuesday said it completed patient enrollment for a new clinical trial of a gene therapy, called AdPEDF, that treats age-related macular degeneration.

The eye disease, which is associated with aging and gradually destroys sharp, central vision, afflicts about 7 percent of Americans ages 40 and older, according to the National Eye Institute, part of the National Institutes of Health.

The GenVec trial, which will be conducted at nine medical centers, involves 20 patients, who will be given one to two doses of the gene therapy.

Clinicians will evaluate vision changes in the patients at the three- and 12-week periods in the trial. Patients also will be monitored one year after treatment to confirm the drug’s safety, the company said.

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