LATEST FDA CASE UNDERSCORES THE DANGER OF BUYING FROM THE SECONDARY DRUG MARKET
Oncology practices are under increasing financial pressure as the cost of doing business increases and reimbursement decreases. The ongoing drug shortages and rising costs of drugs are adding to that pressure, but it is important to keep your practice and patients safe and to avoid purchasing drugs from sources other than legitimate distributors who purchase directly from manufacturers ensuring the safety and integrity of the drugs.
There are two major areas of concern in drug purchasing:
1. Drugs purchased on the "gray market"
2. Drugs that are imported and not approved for sale in this country
"Gray market" vendors are secondary pharmaceutical suppliers that often impersonate legitimate, licensed distributors. They often advertise drugs through fax and e-mail announcements. In the past, these gray market vendors advertised drugs at prices significantly less than our known legitimate distributors. However, they are also currently advertising drugs that are in short supply at grossly marked up prices.
The inflated prices charged for these drugs is not the main concern with the gray market, rather the integrity of the products sold that is of most concern. Drugs sold on the gray market may be mishandled, diluted, mislabeled or counterfeit and thus pose a danger to both the practice and patient.
Illegally imported drugs are another danger area for physicians and patients. The marketing ploy for vendors selling illegally imported drugs is similar to that of the gray market vendors, and in addition to the direct fax and e-mail announcements, they often maintain a Website through which the illegally imported drugs can be ordered. The prices quoted for these drugs are often much lower than the price the practice would pay through their legitimate drug distributor. The FDA cites the gray market and online pharmacies as a major source of counterfeit drugs, reporting that more than half the drugs they purchase online are counterfeit.
In addition, physicians purchasing drugs from the gray market or online pharmacies will likely run afoul of the law. According to the FDA, "it is illegal to import an unapproved drug in to the U.S." and "it is illegal for anyone, including a foreign pharmacy, to ship prescription drugs that are not approved by the FDA in to the U.S., even though the drug may be legal to sell in that pharmacy's country." The definition of "unapproved" includes "foreign-made versions of U.S. approved drugs that have not received FDA approval to demonstrate they meet the federal requirements for safety and effectiveness. It is the importer's obligation to demonstrate to the FDA that any drugs offered for importation have been approved by FDA."
Earlier this month a prominent oncologist pleaded guilty to introducing a misbranded drug (drugs not approved by the FDA for use in the United States) into interstate commerce. According to the FDA Office of Criminal Investigations, in 2010, federal law enforcement investigators began investigating a pharmaceutical wholesaler based in England concerning allegations that the company was importing into the United States prescription drugs approved and labeled for use only outside the United States. The investigation subsequently led to the discovery that the Maryland oncologist had purchased nearly $200,000 of misbranded prescription drugs from the company in 2010. On May 26, 2011, agents executed a search warrant at the oncology office seizing several boxes of misbranded drugs purchased from the company.
Physicians are urged to order drugs exclusively through accredited wholesale distributers. Look for the National Association of Boards of Pharmacy (NABP) Verified-Accredited Wholesale Distributors (VAWD) symbol on the distributor's website. VAWD identifies legitimate and legally operating wholesale distributors and verifies compliance with state and federal laws for wholesale distribution to help protect the public from the threat of counterfeit drugs.
Click Here to see an example of the VAWD symbol of accreditation.
Copied with permission from OpLinc Fast Facts September 13, 2011