Greater Access to Generic Drugs : Part 3

by Food and Drug Administration (FDA)

(Page 3 of 3)

More Efficient Reviews

In 2003, the FDA approved 263 generic drugs. The agency also issued 101 tentative approvals of generic drugs. A tentative approval indicates that final approval of the application is delayed due to patent or exclusivity issues. In 2003, 479 applications were submitted for review. This is up from 392 the year before.

It takes 20 months on average for a new generic drug to be approved by the FDA, and it usually involves multiple review cycles. Very few applications are approved on the first cycle, but about a third are approved on the second cycle. Sometimes multiple review cycles can't be avoided, but the FDA has identified the lack of early communication between generic drug companies and the FDA as one cause for multiple review cycles. With the proposed increases for the generics budget, the FDA plans to increase resources that would make earlier communications possible.

The agency plans to hire more review experts to help speed up the review of generic drug applications so that review time can be reduced by at least two months. The goal is to provide guidance to industry to allow for submission of more complete of applications the first time they are submitted, rather than going through multiple review cycles because of problems. Each round of review generally means many months delay in approval.

The new resources, along with other improvements, such as adding another chemistry review division, are expected to reduce the total time to approval for most new generic drugs by three months or more over the next three to five years. One new approach will be to develop an FDA standard for giving generic companies initial feedback on obvious minor deficiencies within 10 days after the first review cycle is completed. Applicants will have an opportunity to respond and amend an application to try to avoid a whole new review cycle.

Getting the Word Out

"Generic Drugs: Safe. Effective. FDA Approved." That's one of the slogans featured in an FDA consumer education program to promote consumer confidence in generic drugs. The FDA messages have been featured in newspaper articles, posters, and brochures highlighting the safety and effectiveness of generic drugs. Public service announcements have appeared in major magazines and journals, as well as on the radio. Posters and brochures are being distributed at major pharmacies throughout the country. Advertisements rolled around on buses in Chicago, Los Angeles, and New York, and have appeared on billboards in Michigan.

Consumers want lower-cost options for drugs, according to AARP, a nonprofit organization that addresses the needs of people ages 50 and older. In a recent AARP survey of 1,046 people ages 45 and up, 84 percent said generic drugs are important for controlling drug costs. Most also said they usually choose generics over brand names when generics are available. And 24 percent reported not being able to afford a prescription drug when no generic was available.

Richard Cole, senior vice president of corporate communications at Blue Cross Blue Shield of Michigan, says in a statewide survey he conducted in the summer of 2001, most people said they believe generic drugs are equivalent to brand-name drugs. "In the past, the conventional wisdom was that if we increased education about generic drugs, it would look like our only motives were to save money for the company," Cole says. "But consumers reported that they saw it as our job to tell them about generic drug options."

In the fall of 2001, Blue Cross Blue Shield invited all Michigan pharmacies to participate in a competition to increase generic dispensing rates. The goal was to increase generic use among Michigan Blues members by one percentage point, which would result in a $17 million savings for both the company and the customers, Cole says.

Blue Cross Blue Shield challenged pharmacies to develop in-store campaigns and tracked generic dispensing rates. More than 1,000 Michigan pharmacies competed. The prize for the stores with the highest rates: featured spots in a $1 million advertising campaign with the slogan "Generic Drugs — The Unadvertised Brand." Rite Aid won for the retail chain category and Grand Value Drugs of Detroit won for the independent pharmacy category. Cole estimates that the annual savings for Michigan Blues members was more than $30 million.

"People don't want a less expensive drug if they think the quality isn't good," Cole says. "When you or a member of your family gets sick, you don't want second best. But you don't have to worry about that with generic drugs."

About the Author

www.fda.gov
FDA is A United States government body that oversees medical devices, including contact lenses, intraocular lenses, excimer lasers and eyedrops. In the US, these products must be approved by the FDA before they can be marketed.