T

he Food and Drug Administration was established to ensure the safety of food and medicines sold in the United States. That original charter seems to be ignored by the advocates of drug importation, who brush aside legitimate safety concerns to advance a political agenda.

Ensuring access to safe and reliable prescription medications is a paramount concern to U.S. drug manufacturers. And many Americans — including pharmacists and law enforcement officials — want to prevent potentially counterfeit or adulterated foreign drugs from flooding our communities.

STAT’s Ed Silverman recently downplayed the many valid concerns that have been raised about the prospect of opening the United States’s prescription drug market to untraceable foreign products. Here’s why he is wrong to dismiss the risks.

advertisement

The debate about drug importation has been underway for decades. Those who support it have never advanced a responsible plan that would provide the same level of health and safety protections that the FDA has delivered for decades. Its rigorous system of rules and protocols ensure that prescription drugs in this country are safe and effective. It protects those high standards by preventing the sale of imported prescription drugs that are not approved for use in the U.S.

This longstanding policy has generated protests from individuals who want Americans to have greater access to lower-cost medicines. This laudable goal is shared by the biopharmaceutical industry, which is championing market-based solutions to advance it.

We cannot, however, ignore the very real safety risks of buying prescription medicines from other countries. The dangers range from seemingly innocuous concerns about the information listed on drug labels to the more obvious threats posed by counterfeit drugs and a lack of quality control in drug manufacturing in other countries.

In June, former federal judge and FBI director Louis Freeh released the findings of an extensive investigation into the ways drug importation would affect public health, safety, and law enforcement. According to Freeh, importation would increase the threat of counterfeit drugs entering the U.S., exacerbate our nation’s opioid epidemic, and further strain limited law enforcement resources.

Advocates often point to Canada as a potential source of safe drugs. But the Canadian government has said in the past that it does not, and will not, ensure the safety or effectiveness of drugs that are sent across the border.

The FDA issued a very blunt warning about drugs coming from our neighbor to the north: “Drugs coming to the United States from Canada may be coming from some other country and simply passing through Canada” and these drugs could be “counterfeit, contaminated, or sub-potent, among other things.”

Leona Aglukkaq, a former Canadian health minister, affirmed this view in the Washington Post, making it clear that Canada would be a transfer point for drugs made in other countries on their way to the U.S. market. “Allowing Americans to purchase prescription drugs from Canada could have terrible consequences for the citizens of both countries,” she wrote.

Four former FDA commissioners, who served during both Republican and Democratic administrations, also warned Congress in March to reject the idea of drug importation because it could lead to “serious harm” and “undermine American confidence in what has proven to be a highly successful system for assuring drug safety.”

If we can’t guarantee the safety of medicine imported from a trusted neighbor like Canada, what should we expect of prescription drugs shipped to the U.S. from China, India, and elsewhere? Is this a risk worth taking, especially when the Department of Health and Human Services and the Congressional Budget Office have both found it will do almost nothing to actually lower drug costs?

These are serious questions that should not be casually dismissed. This issue is too important to families with a loved one afflicted by a difficult disease; it is too important to patients struggling with debilitating illnesses; and it is too important to seniors who depend on prescription medications to improve their lives.

There are better ways to drive down drug costs. The Council for Affordable Health Coverage recently encouraged policymakers to start by fostering more competition, streamlining the payment process, and accelerating the approval process for generic treatments. There are numerous ways to achieve these goals.

For example, Congress and the Trump administration could take steps to reduce barriers to value-based pricing contracts, in which the price paid for a drug is tied to the outcome it produces rather than the volume of it that is sold.

We should also ease restrictions on the information that drug manufacturers may share with payers and providers, such as information on a drug’s post-market clinical performance, to help payers and providers make better-informed decisions.

Newsletters

Sign up for our Pharmalot newsletter

Please enter a valid email address.

We are fortunate to live in an age of rapid innovation. Researchers are developing breakthrough treatments, and even cures, for a range of once-deadly or debilitating illnesses. These medicines are improving the quality of life for countless individuals.

Let’s not take a step back by undermining the basic safety of those groundbreaking treatments. Instead, we should move forward together on responsible solutions that will promote greater access to affordable medicines while still protecting patient safety.

Jim Greenwood is the president and CEO of the Biotechnology Innovation Organization (BIO).

Leave a Comment

Please enter your name.
Please enter a comment.

  • A simple Colchicine which used to cost pennies now costs $5 a pill just because FDA provided exclusive rights for this 200 year old medicine . Till the greed of Pharma companies are not controlled people will continue to explore other options for medicines

  • Given that many of the ingredients used in the current domestic materia medica are imported from (gasp!) other countries, that the FDA is increasingly at risk of becoming a pharmaceutical industry lapdog, and that BIO is a trade organization that spends a lot of money on lobbying on behalf of the industry, you’ll understand why I’m not convinced by this piece and wonder why STAT even chose to post it.

  • May I observe that certain current BIO members have a pattern of increasing their revenues on declining sales by simply ‘jacking up there prices?’ I also find it impolitic at best to criticize the ‘free pressure’ (although that is certainly in vogue) when Mr Greenwood could have upgraded Congress man Cummings and/ or Senator Sanders in a match of equals instead of having his piece jump off by grinding on the author of Pharmalot.
    Your insult makes you a poor quest, who uses his visit to insult a member of the host family.

    I hope your piece made you feel better, Mr Greenwood, and now I do as well.

  • Complete nonsense. Importing drugs will risk safety more than the multiple cases of drugs being made in foreign factories under FDA license that were either contaminated, had incorrect dosages of the active ingredient, were mislabeled, or were ineffective? Or the contaminated drugs from compounding pharmacies in the US? Or the fact that the US has more cases of drug quality issues than other rich, industrialized, democratic countries? I think this is a Chicken Little scare tactic. Obviously, imported drugs would be subject to our FDA quality standards, foreign drug regulatory agency standards that are similar to the rigor of FDA, and also other international standards like ISO.

  • Then get your members to significantly lower prices. You can’t have it both ways much longer. We have global markets and a big cloud.

  • Before he represented BIO/pharma, Congressman Greenwood said the following, as quoted in the WSJ: “While we would like to stop dangerous drugs from being brought in for abuse and stop people from getting drugs that are counterfeit or bogus, we don’t want to interfere … with an older person getting a better buy.” Source: https://www.wsj.com/news/articles/SB990743981728761586.

    By the way, that same story from 2001 covered the proliferation of personal imports due to the Internet, noting it was a growing problem. Members of Congress that supported importation of lower cost medications used to declare, “show me the dead bodies” or “show me the dead Canadians.” A good comeback against importation, I always thought was, well, we want to avoid dead bodies. Now that 16 years have gone by with tens of millions of Americans having ordered medication online for personal import, it’s worth noting the statistical significance of zero reports of dead bodies, at least when patients ordered non-controlled drugs from pharmacies requiring a prescription. Food for thought.

    Gabriel Levitt
    President
    PharmacyChecker.com

Sign up for our Morning Rounds newsletter

Your daily dose of news in health and medicine.

X