Internet Changes Medication Sales Regulations

The New Jersey Supreme Court found in Perez v. Wyeth Labs, 734 A.2d 1245, 1256 (N.J. 1999), that DTC advertising allows patients to be active participants in their health-care decisions. This finding invalidated the legal fiction that the doctor, not the patient, decides whether a drug is used ' and thereby gave rise to a rebuttable presumption that doctors are not liable for damages resulting from defective pharmaceutical products so long as they adhere to FDA guidelines pertaining to DTC advertising. This protective presumption reduces the liability of doctors who use the Internet DTC elements as part of their medical practice.

The Perez court's findings are widely cited as evidence that doctors and pharmaceutical companies may avoid legal difficulties by adhering to the FDA's regulations regarding DTC advertising. Currently, New Jersey is the only state that maintains this position, while 44 states adhere to the traditional learned-intermediary doctrine in prescription drug cases.

The DTC advertising regulation (21 C.F.R. ' 202(1) (2011)) generally requires a brief and true statement of the side effects, contraindications and effectiveness of the advertised medication. However, the FDA's expansion of DTC medication regulations have been impeded by free speech protections impingement claims. In particular, the right of pharmaceutical companies to be free of governmentally generated forced speech. In West Virginia State Board of Education v. Barnette, 319 U.S. 624 (1943), and later in Wooley v. Maynard, 430 U.S. 705 (1977), the U.S. Supreme Court recognized that the First Amendment also protects a negative free speech right ' the right not to speak.

Online Issues

Internet medication sales difficulties are similar to those raised by sales of any regulated drug, including the sale of counterfeit drugs, the sale of prescription drugs without a valid prescription, the sale of expired or illegally diverted pharmaceuticals, and the marketing of products based on fraudulent health claims.

Both state and federal laws have been enacted to protect medication users from harm resulting from the use of unsafe drugs, counterfeit drugs and the improper practice of medicine and pharmacy. Unfortunately, the Internet makes it easy for individuals to bypass these safeguards when selling drugs to patients. A website can easily be created to look like a legitimate pharmacy, when in fact both the seller and product are illegitimate.

Accordingly, the FDA has provided guidance to Internet sites that promote prescription drugs. In particular, they must comply with current DTC advertising regulations as they relate to print or broadcast advertisements. See Warning Letters and Notice of Violation Letters to Pharmaceutical Companies, Food & Drug Admin. (Jan. 29, 2012).

The Internet is problematic for both drug companies and regulators because of the quantity of information available and the potential for misleading information, regardless of its nature. Consequently, FDA regulations have been enacted to address the issues of liability for information related to medical products posted on the Internet.

In particular, the Internet allows third parties to post misleading information in close proximity to pharmaceutical postings, thus increasing liability of pharmaceutical manufacturers due to a negligence theory. It can be argued that firms that use pharmaceutical Internet postings should be responsible for misinformation posted by third parties on pharmaceutical company-controlled or influenced websites.

For example, Google formerly offered the Sidewiki application, which allowed site visitors to post content to a Google-related page. Such content might include a physician's prescribing of a drug for a purpose other than for what the FDA has approved. While such use is acceptable when the intent is the practice of medicine, it is not acceptable for general publication. Thus, such a posting would result in the FDA imposing liability on the pharmaceutical firm hosting the Google site, over which it had no control.

It should also be noted that the FDA requires any individual who works for a pharmaceutical company, and who posts corrective or other information or contributes to a blog or other forum, to fully disclose the relationship of the author to the company. The Federal Trade Commission (FTC; www.ftc.gov) has also promulgated rules and regulations that require prominently placed disclosures when a blogger has been paid or influenced by an advertiser.

The commission issues rules pursuant to Section 5 of the FTC Act when it has reason to believe that certain unfair or deceptive acts or practices are prevalent in an industry. 15 U.S.C. ' 57a(a)(1)(B). In addition, the commission promulgates rules pursuant to specific statutes, which are designed to further particular policy goals. FTC Guides are “administrative interpretations of laws administered by the Commission.” 16 C.F.R. ' 1.5. Although guides do not have the force and effect of law, if a person or company fails to comply with a guide, the commission might bring an enforcement action alleging an unfair or deceptive practice in violation of the FTC Act.

Social Media

The FDA has issued a draft guidance relating to drug promotion in social media. It addresses how pharmaceutical companies should respond to unsolicited requests for off-label information about their products. The FDA recommends responding to a question about off-label use of the company's drug with a statement that the question concerns an unapproved use, and with contact information for further inquiries.

Last July, the FDA disclosed how prescription drug companies can promote their products on Twitter. The proposed FDA guidelines mandate that the risk information of drugs be included in tweets. Due to Twitter's space limitations (140 characters), the FDA guidelines would effectively ban pharmaceutical companies from the popular social media platform. The FDA recommends that if a producer's tweet was not able to include all of the required and recommended information within the space limitations, then the producer should not use Twitter as a promotional platform. The FDA's guidelines require that for a tweet to be acceptable, it must be truthful and nonmisleading and that “indicated use of the product and the risks associated with use of the product” be included in the message. One acceptable example, according to the FDA, would be “NoFocus for mild to moderate memory loss; may cause seizures in patients with a seizure disorder www.nofocus.com/risk.” Merely by providing just a link to the risks associated with a product would not satisfy the rules.

Jonathan Bick is Of Counsel at Brach Eichler LLC in Roseland, NJ. Reach him at [email protected].

Internet use has changed the way medication purchases are regulated, due in part to patients' free access to information related to pharmaceutical products and medical care. Such access allows patients to be more knowledgeable consumers and rely less upon their physicians' expertise when purchasing medications. Additionally, the Food and Drug Administration (FDA) has promoted Internet medication sales by allowing non-print promotion of medications with less detailed information in the ad itself about side effects and precautions than is required of print advertisements. Consequently, pharmaceutical manufacturers sponsor Internet links to promote direct-to-consumer (DTC) advertising via the Internet, with sales sites one click away.

DTC has benefited both patients and medication sellers. Evidence suggests that direct-to-consumer advertising of prescription drugs increases pharmaceutical sales and helps to avert underuse of medicines, but at the same time leads to potential overuse. See Julie M. Donohue, Ph.D., “A Decade of Direct-to-Consumer Advertising of Prescription Drugs,” N. Engl. J. Med., Aug. 16, 2007. Many DTC marketers have profited by recognizing the opportunities that the Internet offers for reaching consumers.

The Learned Intermediary

The New Jersey Supreme Court found in Perez v. Wyeth Labs , 734 A.2d 1245, 1256 (N.J. 1999), that DTC advertising allows patients to be active participants in their health-care decisions. This finding invalidated the legal fiction that the doctor, not the patient, decides whether a drug is used ' and thereby gave rise to a rebuttable presumption that doctors are not liable for damages resulting from defective pharmaceutical products so long as they adhere to FDA guidelines pertaining to DTC advertising. This protective presumption reduces the liability of doctors who use the Internet DTC elements as part of their medical practice.

The Perez court's findings are widely cited as evidence that doctors and pharmaceutical companies may avoid legal difficulties by adhering to the FDA's regulations regarding DTC advertising. Currently, New Jersey is the only state that maintains this position, while 44 states adhere to the traditional learned-intermediary doctrine in prescription drug cases.

The DTC advertising regulation (21 C.F.R. ' 202(1) (2011)) generally requires a brief and true statement of the side effects, contraindications and effectiveness of the advertised medication. However, the FDA's expansion of DTC medication regulations have been impeded by free speech protections impingement claims. In particular, the right of pharmaceutical companies to be free of governmentally generated forced speech. In West Virginia State Board of Education v. Barnette , 319 U.S. 624 (1943), and later in Wooley v. Maynard , 430 U.S. 705 (1977), the U.S. Supreme Court recognized that the First Amendment also protects a negative free speech right ' the right not to speak.

Online Issues

Internet medication sales difficulties are similar to those raised by sales of any regulated drug, including the sale of counterfeit drugs, the sale of prescription drugs without a valid prescription, the sale of expired or illegally diverted pharmaceuticals, and the marketing of products based on fraudulent health claims.

Both state and federal laws have been enacted to protect medication users from harm resulting from the use of unsafe drugs, counterfeit drugs and the improper practice of medicine and pharmacy. Unfortunately, the Internet makes it easy for individuals to bypass these safeguards when selling drugs to patients. A website can easily be created to look like a legitimate pharmacy, when in fact both the seller and product are illegitimate.

Accordingly, the FDA has provided guidance to Internet sites that promote prescription drugs. In particular, they must comply with current DTC advertising regulations as they relate to print or broadcast advertisements. See Warning Letters and Notice of Violation Letters to Pharmaceutical Companies, Food & Drug Admin. (Jan. 29, 2012).

The Internet is problematic for both drug companies and regulators because of the quantity of information available and the potential for misleading information, regardless of its nature. Consequently, FDA regulations have been enacted to address the issues of liability for information related to medical products posted on the Internet.

In particular, the Internet allows third parties to post misleading information in close proximity to pharmaceutical postings, thus increasing liability of pharmaceutical manufacturers due to a negligence theory. It can be argued that firms that use pharmaceutical Internet postings should be responsible for misinformation posted by third parties on pharmaceutical company-controlled or influenced websites.

For example, Google formerly offered the Sidewiki application, which allowed site visitors to post content to a Google-related page. Such content might include a physician's prescribing of a drug for a purpose other than for what the FDA has approved. While such use is acceptable when the intent is the practice of medicine, it is not acceptable for general publication. Thus, such a posting would result in the FDA imposing liability on the pharmaceutical firm hosting the Google site, over which it had no control.

It should also be noted that the FDA requires any individual who works for a pharmaceutical company, and who posts corrective or other information or contributes to a blog or other forum, to fully disclose the relationship of the author to the company. The Federal Trade Commission (FTC; www.ftc.gov) has also promulgated rules and regulations that require prominently placed disclosures when a blogger has been paid or influenced by an advertiser.

The commission issues rules pursuant to Section 5 of the FTC Act when it has reason to believe that certain unfair or deceptive acts or practices are prevalent in an industry. 15 U.S.C. ' 57a(a)(1)(B). In addition, the commission promulgates rules pursuant to specific statutes, which are designed to further particular policy goals. FTC Guides are “administrative interpretations of laws administered by the Commission.” 16 C.F.R. ' 1.5. Although guides do not have the force and effect of law, if a person or company fails to comply with a guide, the commission might bring an enforcement action alleging an unfair or deceptive practice in violation of the FTC Act.

Social Media

The FDA has issued a draft guidance relating to drug promotion in social media. It addresses how pharmaceutical companies should respond to unsolicited requests for off-label information about their products. The FDA recommends responding to a question about off-label use of the company's drug with a statement that the question concerns an unapproved use, and with contact information for further inquiries.

Last July, the FDA disclosed how prescription drug companies can promote their products on Twitter. The proposed FDA guidelines mandate that the risk information of drugs be included in tweets. Due to Twitter's space limitations (140 characters), the FDA guidelines would effectively ban pharmaceutical companies from the popular social media platform. The FDA recommends that if a producer's tweet was not able to include all of the required and recommended information within the space limitations, then the producer should not use Twitter as a promotional platform. The FDA's guidelines require that for a tweet to be acceptable, it must be truthful and nonmisleading and that “indicated use of the product and the risks associated with use of the product” be included in the message. One acceptable example, according to the FDA, would be “NoFocus for mild to moderate memory loss; may cause seizures in patients with a seizure disorder www.nofocus.com/risk.” Merely by providing just a link to the risks associated with a product would not satisfy the rules.

Jonathan Bick is Of Counsel at Brach Eichler LLC in Roseland, NJ. Reach him at [email protected].