FDA Warns Physicians About Using Unapproved IUDs

Disclosures

July 23, 2010

July 23, 2010 — Physicians should avoid using intrauterine devices (IUDs) that are not approved by the US Food and Drug Administration (FDA), even though they can import these devices from other countries at bargain prices, the agency announced yesterday.

Patient health is at risk when an unapproved product's "identity, purity, source, handling, and storage cannot be verified," stated Theresa Toigo, director of the agency's Office of Special Health Issues in a letter yesterday to healthcare providers.

Physicians also are at legal risk for distributing unapproved products and committing insurance fraud, Ms. Toigo pointed out.

The FDA is investigating cases of physicians implanting imported, unapproved IUDs in patients in Rhode Island and several other states. The IUDs include unapproved versions of FDA-approved products such as Mirena (Bayer HealthCare Pharmaceuticals), ParaGard (Duramed Pharmaceuticals), and Implanon (Schering-Plough), as well as T-Safe (Eurim Pharm), which is not FDA-approved.

Physicians violate the law against using drugs and medical devices that have not been approved by the FDA, even if the product has been approved by the country they are importing it from, according to the agency. Although the product from the foreign country may be identical to the one approved by the FDA, it may not comply with FDA requirements for manufacturing, storage, shipping, and labeling. A simple example is a foreign product that comes with an insert written in a language other than English.

The FDA also warns that imported drugs and devices advertised as identical to FDA-approved products may not live up to this claim and may instead be unsafe and ineffective counterfeits. Furthermore, a product advertised as Canadian in origin may actually be from another country.

"FDA cannot assure the authenticity, safety, or effectiveness of drugs from foreign countries," the agency states on its Web site.

In an announcement issued to consumers yesterday, the FDA advised women who think they may have received an unapproved IUD to talk to their healthcare provider about whether they should have the device replaced.

Price Difference Between Approved and Unapproved IUDs Is Tempting

Physicians have had an economic incentive to use imported drugs and devices not approved by the FDA. Physicians can buy a Mirena IUD from Canadian Internet pharmacies for roughly $200, for example. If they buy the FDA-approved version through sanctioned channels in the United States, the price can shoot up beyond $800.

Those who defend the use of imported IUDs say that obstetrician-gynecologists lose money when they implant an FDA-approved version of Mirena because when they bill insurers for reimbursement, the fee they receive is less than what they paid for the device. That loss, they contend, is particularly onerous for obstetrician-gynecologists who treat a heavy volume of Medicaid patients.

By using less expensive IUDs from Canada, the argument goes, obstetrician-gynecologists can avoid losing money on the procedure and even make a small profit that offsets subpar fees for other services. However, billing Medicaid and other third-party payers for an unapproved IUD can expose the physicians to fraud charges.

Physicians who purchase drugs and medical devices online can reduce the chance of inadvertently receiving unapproved products by patronizing only state-licensed pharmacies or distributors located in the United States, according to the FDA. Legitimate Internet pharmacies display a seal from the National Association of Boards of Pharmacy called the Verified Internet Pharmacy Practice Sites seal. A list of verified pharmacies is available at on the National Association of Boards of Pharmacy Web site.

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