On March 18, the House Government Reform Committee held a hearing on the Internet Pharmacy Consumer Protection Act (H.R. 3880). The measure would establish disclosure standards for legitimate Internet pharmacies; prohibit Internet sites from selling or dispensing prescription drugs solely on the basis of an online questionnaire; and provide additional authority for states to take action against illegal Internet pharmacies.
In his opening remarks, Chair Tom Davis (R-VA) stated, “Prescription drugs are well regulated in our country, by a system that includes pre-market approval by the FDA [Food and Drug Administration], state licensure of healthcare practitioners who are allowed to prescribe, and state oversight of pharmacists and pharmacies. However…the Internet creates an easy environment for illegitimate pharmacy websites to bypass traditional regulations and established safeguards for the sale of prescription drugs.”
FDA Associate Commissioner for Policy and Planning William Hubbard said that patients who buy prescription drugs from illegal sites “are at risk of suffering adverse events, some of which can be life threatening. These risks include potential side effects from inappropriately prescribed medications, dangerous drug interactions or drug contamination.” He advised all consumers to check with their state’s board of pharmacy or the National Association of Boards of Pharmacy to find out if the online pharmacy has a valid license and has met all state quality standards.
Mr. Hubbard summarized the steps taken by the FDA to minimize the dangers to public health posed by the sale of drugs on the Internet. They include engaging in public outreach and education; partnering with professional organizations such as the American Medical Association; coordinating action with state and other federal agencies; cooperating internationally; and strengthening enforcement tailored to the Internet environment.
Mr. Hubbard also highlighted a number of enforcement actions taken by the FDA, including action against four Internet pharmacies selling counterfeit contraceptive patches. “The counterfeit contraceptive patches were purported to be an FDA-approved product,” he stated. “Instead, customers receive packages of patches without the active ingredient necessary to make the patches effective. Moreover, the counterfeits were sent in simple plastic zip-lock bags without identifying materials, lot numbers, expiration dating or any other labeling information needed to safely and effectively use this prescription product.” Mr. Hubbard explained that the FDA worked with the Internet service provider to have service to the sites shut down. In addition, the FDA Office of Criminal Investigation is working with the manufacturer and other federal agencies to further investigate the matter. Mr. Hubbard also noted, “Photos contrasting the legitimate contraceptive patch with the counterfeit are displayed on FDA’s website. Women who have been sent contraceptive patches lacking proper labeling or not having the appearance of the approved product as described above should not use the product and should contact their healthcare providers immediately.”
