EpiPen has dominated the news lately with a public outcry over sharply rising prices on essential drugs. As drug prices rise in the United States, many patients and doctors turn to suppliers in other countries to save money, prompting action from the United States Food and Drug Administration (FDA). However, a new report questions this crackdown on medication imports and whether the FDA seems to be favoring drug companies over doctors and patients.
The report comes from Sarah N. Lynch who published her findings September 8th on Reuters.com. As critics complain the FDA is protecting drug companies, not consumers, the Reuters report looked into the FDA’s investigations of foreign-imported drugs and how effective those investigations really are.
The reporter looked into the Office of Criminal Investigations, a branch of the FDA created in response to a generic drug scandal in the 1990s. With a $77.3 million annual budget, the office seems to spend most of its efforts these days acting as what some have called the “Botox police.”
The wrinkle-reducing drug Botox can cost more than $500 a vial in the U.S., with prices rising periodically, but the same vial may cost a couple hundred dollars less overseas. These cost-savings make Botox a popular drug for doctors to purchase from other countries. Although the drug itself may be the same, other countries such as Canada and England tend to regulate drug prices, restricting how much the pharmaceutical companies can charge for a particular drug. In the U.S., meanwhile, there are no restrictions. This means pharmaceutical companies are free to charge however much they want for their products, knowing that if someone needs the drug, they have no choice but to pay.
With so many doctors importing cheaper drugs like Botox from other countries, the Office of Criminal Investigations (OCI) has been trying to crack down on the practice. From the FDA’s perspective, these drugs may be counterfeit and harmful to patients, possibly not stored at the correct temperature and triggering adverse effects. However, in many cases, the drugs are simply labeled differently from those for sale in the U.S. through official channels. The OCI calls these foreign unapproved medical products or “FUMP”.
Reuters examined 140 lab reports for Botox seized by the OCI. According to these reports, most of the Botox turned out to be real Botox, not counterfeit, but packaged in a vial labeled for use in another country. As it turns out, these drugs the FDA considered to be dangerous were actually not more or less harmful than locally-purchased drugs.
Between 2012 and 2015, Reuters discovered, the OCI devoted more than 218,000 man hours to these types of foreign unapproved medical products cases. Between 2009 and August 1, 2016, the office opened 878 investigations, resulting in 110 convictions. More than half the cases were closed without any action at all. Reuters compared this to the Environmental Protection Agency (EPA) who saw 71 percent of their open cases result in criminal charges. Some accuse the FDA of opening cases it cannot win, wasting prosecutors’ time.
There are various reasons the open cases do not result in charges. In some situations, prosecutors refused to pursue the cases since the Botox was authentic. In other cases, doctors had purchased small amounts, including one doctor who had only purchased some foreign-sourced Botox for his wife. Most doctors also use Botox for cosmetic purposes, not covered by insurance, so the cases did not involve problems such as false insurance claims.
In addition to the allegations of wasting time and money, some accuse the FDA of working for the pharmaceutical companies. According to a spokesman who talked to Reuters, Allergan, who makes Botox, frequently passes on information to the FDA. The company hears of an unauthorized Botox sale and notifies the agency, and the agency then investigates the doctors involved. This can be beneficial to Allergan as they block doctors from purchasing Botox from other countries, instead forcing the doctors to pay the inflated U.S. prices. Although the FDA maintains they simply respond to complaints from others, including Allergan, some accuse the agency of protecting the interests of pharmaceutical companies over doctors. Some drug companies allegedly go so far as to hire undercover private investigators to make purchases, then passing on the information to the FDA.
Another point of contention for some is putting the responsibility to identify misbranded packaging on the doctors. Most doctors do not receive training in identifying misbranded drugs, and the differences are often subtle, like including foreign languages in the package insert or failing to include the words “Rx only” on the package. Even an FDA expert once testified he had trouble identifying foreign labels until he received specific training. Many of the agency’s cases are dismissed because there was no proof of intent, no proof the doctors knew they purchased a misbranded drug.
Some clinics accuse the OCI agents of going much too far to track questionable Botox. Healthcare workers complain that agents will come into their clinic, threaten the staff and use scare tactics, then rifle through cabinets for drugs they believe look like they may have come from other countries. In one particular case, the agency’s search was deemed illegal and inadmissible in court. According to the documents Reuters obtained, many of the seized drugs turn out to be genuine Botox anyway.
According to the Reuters report, only a few doctors have faced prosecution for buying foreign, unapproved Botox. Most doctors purchase small amounts, under $1,000, and some are simply turning to cheaper drugs, such as anti-nausea drugs, to help impoverished patients. Since the cost-savings benefits outweigh the risks, doctors continue to source drugs such as Botox overseas.
Some accuse the FDA of wasting resources and money pursuing cases they cannot prosecute, cracking down on doctors buying small amounts of Botox and other drugs instead of investigating more serious problems, such as sales of counterfeit painkillers on the street. Meanwhile, doctors and patients continue to turn to cheaper foreign drugs available online as drug prices continue to rise dramatically in the U.S.