Earlier this week, a report (the “FGI Report”) opposing prescription drug importation proposals was released by the law firm of Freeh, Sporkin and Sullivan LLP and the Freeh Group International. Both organizations are headed by former FBI Director, Louis Freeh. I’m hesitant to criticize reports authored by dedicated Americans who spent years in public service protecting the safety of the American people in federal law enforcement. On the other hand, the intent of tacking the name of a venerated American patriot on a report that mirrors the lobbying agenda of the pharmaceutical industry is clearly being used to deter voices opposed to that agenda.
Summing it all up: this report was commissioned, I believe, by the drug company-funded group Partnership for Safe Medicines or a similar organization. As noted in the report’s title, it’s an addendum to an earlier report published in late 2017, one that was promoted at a Partnership for Safe Medicines media event at the National Press Club.
The FGI Report essentially restates the main points from the 2017 report in addition to identifying new authorities that federal agencies possess in order to combat opioid abuse. There is little in the report that actually addresses current drug importation proposals. However, it does criticize the Trump administration’s drug importation idea, proposed by the Secretary of Health and Human Services Alex Azar, which calls for a working group to discuss limited drug importation of lower-cost, foreign-approved versions of single source medications.
It seems that the main intent of the report is simply to bring media attention back to the fact that former FBI director Mr. Freeh has stated that drug importation reforms are potentially dangerous.
Taking a step back from the debate about federal and state legislation on prescription drug importation, let’s look at the data on how people are benefiting already from lower drug prices in other countries.
According to survey research by the Kaiser Family Foundation, about 20 million Americans have imported medicine because it’s less expensive abroad. Despite the federal prohibition, consumers are never prosecuted. Many people have no other choice than to personally import medications. In fact, 29% of Americans don’t properly fill a prescription each year because of price. Equally as important, filling prescriptions at licensed pharmacies in other countries for personal import is very safe. And the prices are not just a few bucks less, but sometimes 90% lower. Nothing in this new report refutes the fact that safe personal medicine importation is a lifeline of affordability for patients in America who can’t afford the prices at their local pharmacies.
Whether traveling to Canada, sticking to properly verified international online pharmacies, or city and country programs that offer retirees and employees an international pharmacy options, personal drug importation already works.
The safe manufacture, labeling, distribution, prescribing and dispensing of prescription medicine are regulatory matters. The question should be how to best regulate imports of safe and effective pharmaceuticals to bring down costs. The FGI Report is focused on the role of law enforcement as it relates to pharmaceutical importation. Treating this issue as criminal already wrongly directs public attention to a dark narrative about importation.
The FGI Report seems to ignore that drug importation is already legal. It’s a major part of the U.S. supply chain, so let’s stop pretending that most of the pharmaceuticals we ingest are made in America. 80% of the active pharmaceutical ingredients that go into so-called American drugs are not made here, with an overwhelming share made in India and China. We looked at the top 100 brand-name drugs sold in the U.S., using 2015 data, and 70% of them were not made in the U.S. Those same drugs are sold in other countries at much lower cost. Importation proposals seek to access those prices.
For the most part, the FGI Report doesn’t address federal and state importation proposals at all, but essentially claims they can’t possibly be good.
The FGI Report is specifically dismissive of Secretary Azar’s idea for new, limited drug importation of off-patent medicines where there is limited competition in the U.S. marketplace:
“I am certain they cannot propose a solution that would effectively protect our prescription drug supply under any drug importation proposal, even if limited in nature.”
Let me give one example of how that’s not true.
The heart of Secretary Azar’s idea is to identify foreign versions of FDA-approved off-patent medicines, manufactured under CGMP (Current Good Manufacturing Practices), that have either no competition or very little competition. So we ask the question, can such drugs be identified? Yes. The drug Daraprim is a clear example of how Secretary Azar’s program could work. In 2015, under the leadership of Pharma bro Martin Shkreli, Turing Pharmaceuticals raised the price of Daraprim from $13.50 to $750 a pill in one night. That drug is made by a contract manufacturer in North Carolina. After that story became national news, we wrote in the Huffington Post that GlaxoSmithKline’s version of Daraprim, was available in the UK for $6 a pill. That GlaxoSmithKline version is considered “unapproved” under federal law, even though it’s made by GlaxoSmithKline and sold in UK pharmacies. Secretary Azar proposes providing those types of medications with approval for importation because they will infuse competition into the U.S market. It seems very reasonable. It’s not unlikely that Secretary Azar got the idea from Dr. Aaron Kesselheim and Thomas J. Bollyky who proposed it in May 2017.
Law enforcement is one aspect of keeping our pharmaceutical supply safe but not more important than making sure people can actually afford the medicine they are prescribed. The FGI Report is correct that we must give federal agencies what they need to combat dangerous online pharmacies, counterfeit drugs and the opioid crisis, with a particular emphasis on illegal imports of fentanyl and other narcotics. On that last point, Congress should make sure that federal funding is not diverted from stopping illegal opioid drug trafficking, such as imports of fentanyl ingredients from China, to actions that curtail access to lower cost prescription medicine.
There are some excellent recommendations in the report that stay focused on these real public health threats, but such activities do not preclude new regulations to permit importation of safe and effective lower-cost medicines from Canada and other countries. Those recommendations include:
- The enhancement of federal sentencing penalties for the trafficking of fentanyl and fentanyl analogues.
- Federal law enforcement agencies expressly targeting Drug Trafficking Organizations and other individuals who produce and sell counterfeit pills, including through the internet. But ensuring that such enforcement does not veer off toward targeting safe international online pharmacies.
- A coordinated federal/DEA effort to prevent, monitor and detect the diversion of prescription opioids, including licit fentanyl, for illicit distribution or use.
Let’s harness the knowledge imparted about law enforcement within the FGI Report so that we’re laser focused on the sources of real public health threats: such as acts by drug companies that lead to the overprescribing of opioid drugs; stopping illegal fentanyl and other opioid drugs from getting into the country; increasing penalties against people who actually make fake medicine and intentionally sell it, with a particular focus on counterfeit drugs made with fentanyl ingredients. On the other hand, let’s not conflate those problems with reforms to improve access to lower cost imported medicines.Tagged with: Alex Azar, FGI report, Louis Freeh, Partnership for Safe Medicines