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FDA misleads Congress about drug importation

Properly licensed foreign pharmacies help Americans access medicines that they can’t afford here. Counterfeit drug makers and sellers, fentanyl and opioid dealers, and dangerous pharmacy websites are worthy targets of serious regulatory or criminal enforcement actions. There’s no gray there.

An article I wrote that was recently published in The Nation hopefully brings to greater public attention the FDA’s conflation of clearly safe channels for personal prescription imports with counterfeit drugs, the opioid crisis, and rogue online pharmacies. That conflation, one associated with the media relations work of the pharmaceutical industry – is used to justify FDA enforcement actions that exacerbate the crisis of high drug prices by threatening programs that facilitate prescription fulfillment from foreign, licensed pharmacies.

Originally published in The Nation:

Prescription drugs can cost 80 percent less in Canada, Australia, and the UK—why isn’t the FDA supporting safe importation?

The one issue that unifies our divided America is the high cost of prescription drugs. Congress has taken the hint, decrying the greed of the pharmaceutical industry at hearings that seem to be held almost weekly, and sounding the alarm for immediate action, which seems to never come. The Kaiser Family Foundation recently reported that one in four Americans struggle to fill their prescriptions because of cost, which can often lead to illness or even death. We are in the midst of a public-health crisis.

One of the solutions currently working its way through Congress would permit patients to obtain lower-cost medication from pharmacies in Canada and other countries, where drug prices are frequently as much as 80 percent lower than those at US pharmacies. Americans haven’t waited for Congress to act, however: Despite the fact that it’s federally prohibited under most circumstances, an estimated 19 million Americans have already imported medicines for personal use because of cost. To import, some travel to Canada and Mexico, while others order online or through programs connecting them with international pharmacies. For many, it’s great savings, but for others it’s their only option.

While individuals are never prosecuted for this technical violation of law, the FDA’s non-enforcement policy does not preclude the agency from harassing businesses that facilitate safe personal drug importation. Where serious dangers lurk, the FDA does and should take enforcement actions, including against rogue online pharmacies, opioid imports, and counterfeit drug sales. But that focus and enforcement activity, funded by public moneys, should not be misused to protect the profit margins of drug companies.

On February 27, in a hearing of the House Appropriations subcommittee responsible for FDA funding, Congresswoman Chellie Pingree asked then–FDA Commissioner Scott Gottlieb for his thoughts on drug importation from Canada, noting that people from Maine can buy much lower cost medicines across the border [watch from 1:34:23 for this exchange]. Commissioner Gottlieb asserted that people who buy medications while in Canada are safe.

In contrast, Gottlieb voiced his “deep concerns” with online pharmacies “purporting to source their drugs in Canada or other First World markets but are not.”

“We are seeing a lot of counterfeit drugs being sold through those channels,” asserted Gottlieb, going on to say that there is “a lot of investigative activity and some fairly egregious things [the FDA] are finding when we look at these websites…so we have deep public-health concerns.”

The commissioner’s remarks would lead Congress to believe that the FDA is spending taxpayer dollars investigating and taking actions against counterfeit drug sales, rogue online pharmacies, and serious threats to the public health. Yet, a day before that testimony, the FDA issued a warning letter to a company called CanaRx Services, Inc. to stop facilitating imports of medicines. In its press release, the FDA weaves a sinister narrative, using language that is eerily similar to that employed by organizations and experts funded by drug companies: “Operations like CanaRx use their names to imply that patients are receiving medicines approved in Canada, when it’s likely that patients are receiving medicines from other countries, and which may be sub-potent, super-potent or counterfeit.”

Which would be all fine and good, if it were even a little bit true.

CanaRx is contracted by self-insured cities, schools, companies, and other organizations to fill the prescriptions of municipal retirees and employees at licensed pharmacies in Canada, Australia, and the United Kingdom. No counterfeit drugs have been discovered, and there is no evidence that the medicines are coming from any other country than those mentioned by CanaRx. The company has helped save American taxpayers and patients about $250 million over the past 20 years. Far from being a dangerous fraud, CanaRx is actually a perfect example of how we can make saving money on personal drug importation safe.

They’re also not even an online pharmacy. CanaRx and the websites they work with are available only to participants in the program. In contrast, international online pharmacies are available to the general public. While many online pharmacies are rogue sites, others are very safe, like the ones my company verifies. Just ask Roger Bate, an economist and expert on counterfeit drugs from the conservative-leaning American Enterprise Institute: His peer-reviewed research and testing over the last 10 years show that properly verified international online pharmacies are just as safe as US pharmacies.

This reality foils the FDA’s public stance on the issue of online pharmacies, and it should not be used to blemish non-online pharmacy options, like CanaRx’s program. The evidence shows that its services are successful at keeping pharmaceutical costs down, safely. In fact, that’s probably why the Pharmaceutical Researchers and Manufacturers of America (PhRMA), the pharmaceutical industry’s trade group, applauded the FDA’s efforts to crack down on CanaRx.

The FDA needs to properly inform—not mislead—Congress about how and why our taxpayer money is being spent on investigations related to prescription-drug importation, especially when these investigations serve mainly to protect one industry’s profits at the expense of tens of millions of Americans who cannot afford their medication.

Let’s be perfectly clear: Programs like CanaRx and safe personal drug importation, generally, whether on- or off-line, are vital for American patients who need access to the much lower prices from pharmacies in other countries. For example, the drug Januvia, which treats type 2 diabetes, costs about $1,700 for a three-month supply at chain pharmacies in the United States. Januvia is manufactured by the drug company Merck in the UK. A three-month supply of the exact same drug can be purchased online from a UK pharmacy for just $275. The reason that’s the case is because our system is broken.

Instead of trying to stop safe personal-medicine imports, let’s reduce the demand for them by substantially lowering drug prices here. My organization, Prescription Justice, supports ending the ban on Medicare drug-price negotiations, stopping patent games that prevent lower-cost generics from coming to market, and removing giveaways to drug companies from trade agreements, like the revised NAFTA fiasco, that seek to extend the pharmaceutical industry’s monopoly pricing on expensive biologic drugs. We also support legislation to officially legalize importation of lower-cost prescription drugs—but lowering prices here would mitigate the need for such importation.

Until we actually lower prices in the United States, the FDA should not aggravate the crisis of high drug prices in America by trying to shut down CanaRx or other avenues of safe personal-drug importation. That would just be protecting Big Pharma’s profits, not patients.

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