FDA Generic Drug Promotional Campaign Features Newspaper Articles

FDA's educational campaign to encourage the use of generic drugs will be launched in late July with an informational article appearing in local newspapers nationwide.

The article, titled "Generic Drugs: What Everyone Should Know," placed under the slogan "Protecting Our Health," should start running the week of July 29, and will continue appearing for up to a year and a half, FDA said.

The agency paid North American Precis Syndicate to develop the article and disseminate it to local newspapers and gazettes around the country.

The article notes that 44% of U.S. prescriptions are filled with generics, and that besides having the same "medicinal qualities (and side effects)" as brands, generics "tend to have one additional benefit: lower cost."

The article points out that generic drugs are "identical" copies of brand-name products in terms of "dosage, safety, strength, how it is taken, quality, performance and intended use," and that both brand-name and generic manufacturing facilities "must meet standards of good manufacturing processes."

Office of Generic Drugs Director Gary Buehler is quoted as saying that "people can use [generics] with total confidence." The article also notes that "brand-name firms account for an estimated 50% of generic production," often making copies of their own drugs.

The article features a logo of an "FDA-approved" seal. The FDA website, along with "your physician, pharmacist or insurance company" are then cited as sources of further information.

The campaign was requested in a fiscal year 2002 agriculture appropriations conference report, which allotted $250,000 to develop an education program promoting the use of generics (¹ (Also see "Patent Extensions’ Cost To Be Evaluated By FDA Under Ag Approps Request" - Pink Sheet, 19 Nov, 2001.), p. 10). The FY 2003 House ag approps bill report states that "not less than $400,000" should be spent on continued generic education activities (² , p. 5).

In addition to the newspaper article, FDA has completed full-color public service announcements that it hopes to start placing in consumer magazines and professional journals as early as this fall.

"You know that question that goes through your mind when you take your generic drug?" one of the PSAs asks. "Here's the answer," the PSA declares, referring to a large "FDA-approved" seal.

Another PSA for consumers recommends, "If you're experiencing anxiety about taking your generic drug, read this ad and repeat as needed." Underneath is the text all three PSAs share: "All generic drugs are put through a rigorous, multi-step approval process. From quality and performance to manufacturing and labeling, everything must meet FDA's high standards."

"We make it tough to become a generic drug in America so it's easy for you to rest assured." An enlarged-font, bolded message below the text reflects the central message of the agency's campaign: "Generic Drugs: Safe. Effective. FDA Approved."

A third PSA is aimed at healthcare professionals and will run in journals. It asks, "Think it's easy becoming a generic drug in America? Think again." Below is a picture of a large caplet with pointers to various caplet parts labeled "assured quality," "consistent labeling," "rigorous manufacturing standards," "performance evaluation," "same drug" and "purity check."

In order to facilitate dissemination, FDA also plans to share the PSAs with pharmacy and drug education organizations and the five major HMO networks. The agency hopes to work with Blue Cross/Blue Shield, the National Association of Chain Drug Stores and the National Council on Patient Education & Information.

NACDS says it is considering partnering with FDA pending further review of the materials. The agency plans to share and obtain feedback on its PSAs at NACDS' annual pharmacy and technology conference Aug. 10-14 in San Diego. Dissemination of information and "give-away items" at other professional conferences is also planned, FDA said.

FDA expects the campaign also will eventually include brochures distributed in drugstores, movie ads, subway and bus ads, radio announcements in both English and Spanish, and a "consumer-friendly" website.

Pharmacist involvement and education is another goal of the campaign, and FDA will develop a web-based continuing medical education course for pharmacists on generic drug approval.

The agency plans to eventually develop more education materials tailored to pharmacists and physicians, but may first conduct surveys to assess their knowledge of the generic review process.

FDA is not the only organization launching an educational campaign on generics: Michigan Blue Cross/Blue Shield's campaign touts generics' safety and efficacy and also their cost savings potential.

Some of the advertisements used information from FDA's website with the agency's permission. One ad with pictures of smiling pharmacists declares, "Michigan pharmacists trust FDA-approved generics," and instructs consumers to "demand generics!" Underneath is a logo that states, "generic drugs: the unadvertised brand."

At the beginning of August, Michigan BC/BS plans to launch billboards featuring the "Safe. Effective. FDA Approved." tagline, with accompanying sponsorship logos of both Michigan Blues and FDA. The campaign will have a different theme every month.

The campaign includes a generic vs. brand-name drug cost comparison "reference card" for physicians and patients, and a series of advertisements in local newspapers and business journals that ran in May and June.

The plans have made an estimated 15-to-1 return on investment since the campaign's launch. The Blues are spending $1 mil. on the campaign.

Interest in the campaign from other health plans has prompted the Michigan Blues to sponsor an upcoming marketing/communications conference in September on its materials and how to use them.

The Michigan BC/BS has trademarked its logo and materials and is offering them free of charge to any nationwide plan willing to give it credit.

Over the past year, the Michigan Blues have sponsored coupons for generic copays for consumers and a pharmacy competition for the most conversions to generics (³ (Also see "Michigan Blues Waiving Generic Copays; Coupon Program Targets 25 Brands" - Pink Sheet, 26 Nov, 2001.), p. 19).