5. How will consumers benefit from this new proposal?
6. What are the disclosure requirements and what is their purpose?
7. Under the proposed new authority, how can a consumer know if an Internet pharmacy is legitimate?
9. Why does FDA want administrative subpoena authority under this new initiative?
12. Will FDA take any action on its own without state involvement?
13. How will the new proposal affect the current VIPPS program?
14. How will this new initiative affect Internet pharmacies that already have a VIPPS seal?
15. What actions will FDA take against foreign Websites selling drugs under the new proposal?
FDA, along with state boards of pharmacy and medicine, is responding to the increasing number of Websites offering prescription drugs that appear to violate state and federal laws. While the Internet has opened up new opportunities for consumers to purchase products more conveniently, the Internet also provides unscrupulous individuals with a powerful new tool to unlawfully promote and sell drugs.
FDA is devoting more resources to enforcement efforts and undertaking a public education campaign to help consumer's shop wisely online. In addition, the Administration is seeking $10 million in the next fiscal year budget to further FDA's enforcement efforts and is proposing legislation initiative to enhance FDA's ability to protect consumers who purchase pharmaceutical products on the Internet.
The legislative proposal has not yet been transmitted to Congress. The Administration has released information on the general outline of the proposed initiative, however, the legislative language is still being crafted and reviewed prior to its formal transmission to the Congress.
The Administration plan has focused primarily on prescription drugs, but the issue of whether Websites selling other FDA-regulated products will be covered is still under discussion.
The Administration proposal would require that online pharmacies post information on their Websites that will enable consumers and regulators to know who operates the pharmacy, how they can be contacted, and where the pharmacy is located and licensed.
The proposal also would require online pharmacies to be certified as meeting all applicable state and federal laws and regulations. Operating a pharmacy without meeting such requirements could subject the operator to stiff penalties.
Finally, the proposal would give FDA administrative subpoena authority, which would enable it to investigate violative sites more rapidly and effectively.
5. How will consumers benefit from this new proposal?
Consumers will have confidence that they are purchasing prescription drugs from legitimate sites that meet state and federal requirements. As a result of the certification requirements, consumers will be better able to identify legitimate sites.
6. What are the disclosure requirements and what is their purpose?
Under the Administration plan, Internet pharmacies will be required to post information on their Websites that will enable consumers and regulators to know who operates the pharmacy, how the pharmacist may be contacted to respond to problems or concerns, and where the pharmacy is located and licensed. These requirements will give consumers the same opportunity to communicate with the Internet pharmacist as they have with the traditional storefront pharmacist, and it will also diminish the ability of unscrupulous operators to use the Internet to remain anonymous.
7. Under the proposed new authority, how can a consumer know if an Internet pharmacy is legitimate?
Under the proposal, all pharmacy sites that meet state and federal requirements would have an easily recognizable indicator (such as a seal) that the pharmacy operating the Website has been certified as meeting all applicable state and federal requirements. In this manner, consumers can be confident that they are buying quality medicines from a legitimate pharmacy operation. Pharmacy sites not certified would be operating in violation of the law and should be avoided by consumers.
The new initiative will not preempt state law. In fact it will enhance the ability of States to bring actions against illegal prescribers or dispensers of prescription medications. FDA will continue to defer to states to regulate the practice of medicine and pharmacy.
The proposal adds little in the way of additional requirements for Internet pharmacies. Internet pharmacies will have to disclose information that is available to consumers in traditional storefront pharmacies and demonstrate that they are properly licensed under already existing state requirements. It is similar to authority other agencies have now.
9. Why does FDA want administrative subpoena authority under this new initiative?
To obtain records needed for investigating suspect Websites, FDA has often had to rely on the issuance of grand jury subpoenas. This is a time-consuming process that has led to unnecessary delays in investigating potentially illegal Websites. The authority being proposed is limited in scope, but would allow FDA to acquire certain information by obtaining a subpoena administratively, thus saving precious investigative time.
Under the proposal, FDA and/or the states would have authority to take action against any online site that does not meet certain standards. In addition, the proposal provides for civil money penalties for the illegal sale of prescription drugs. Depending on the nature and severity of the violation, a person may face up to $500,000 in civil money penalties and/or criminal sanctions. These penalties will provide a more effective deterrent to rogue operators that pose a threat to the health of Americans.
The proposed increase in resources will allow FDA to monitor more sites than is possible with current resources. Increased resources will help the Agency routinely search the Internet for violative Websites and target problematic sites with investigative and possible enforcement action.
12. Will FDA take any action on its own without state involvement?
FDA intends to work closely with state authorities on issues that impact the practice of pharmacy or the practice of medicine, which have traditionally been regulated by the states. FDA does not intend to change this long-standing policy. FDA will work with the states in a cooperative manner to bring enforcement actions under state law, federal law, or both as appropriate. The Agency has developed formal agreements with the National Association of Boards of Pharmacy and the Federation of State Medical Boards and we are currently working with the National Association of Attorneys General. These agreements outline the respective roles of these bodies towards cases that may involve the practice of pharmacy or the practice of medicine. Although FDA has authority in this area we have traditionally relied on the state licensing and regulatory boards for enforcement actions and we will continue to do that with the new proposal.
13. How will the new proposal affect the current VIPPS program?
The VIPPS (Verified Internet Pharmacy Practice Sites) program is a voluntary regulatory program directed by National Association of Boards of Pharmacy (NABP). It is used in conjunction with existing laws to assure consumers that the site from which they purchase has met appropriate state and federal requirements.
The new proposal envisions a certification program similar to VIPPS, but with mandatory, rather than voluntary, participation in order for an online pharmacy to sell prescription medications to a consumer. The program will give consumers confidence that the site they are visiting is a legitimate pharmacy site.
14. How will this new initiative affect Internet pharmacies that already have a VIPPS seal?
This will not become clear until the plan becomes a formal legislative proposal, but it is likely that pharmacy sites already awarded the VIPPS seal will have already met most, if not all, of the criteria that will be required under the new certification program.
15. What actions will FDA take against foreign Websites selling drugs under the new proposal?
Foreign sales pose a difficult challenge for U.S. law enforcement. Neither state nor federal authority can reach into foreign countries to enforce laws against illegal Internet activity. FDA, the Customs Service, the Postal Service, and the Drug Enforcement Administration have authority to stop drugs illegally imported into the U.S. when the product reaches the U.S. border. However, one element of the proposal, the "seal" indicating that a site meets the appropriate legal requirements, will at least allow consumers to identify legally licensed sites that display the seal. Consumers can be warned to avoid those that do not.
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