As reported in DigitalJournal this past Wednesday, at a press conference in Keene, NH, Congressman Ron Paul (TX-14), Republican candidate for president, accused the pharmaceutical industry and the FDA of being in “bed together.” He derided their arrangement, characterized by a revolving door of people repeatedly switching jobs back and forth between the FDA and pharmaceutical industry, as collusion to reduce competition in the pharmaceutical marketplace, resulting in higher drug prices. When it comes to online pharmacies, personal drug importation and drug prices, Congressman Paul’s critique resonates all too loudly.
The pharmaceutical industry, through their main trade association Pharmaceutical Researchers and Manufacturers of America (PhRMA) has lobbied vigorously to keep safe personal drug importation illegal, and to scare Americans away through its media relations juggernaut and funding of the Partnership for Safe Medicine from buying safe and affordable medication online from Canada and other countries. PhRMA even commissioned the publication of a novel about a terrorist conspiracy – The Karasik Conspiracy – in which terrorists attack Americans with bad drugs sold from Canada! This effort backfired and they pulled the plug on the publishing company, which then went ahead and published a different version of The Karasik Conspiracy novel in which a pharmaceutical giant poisons medications to protect its profits.
The efforts of the FDA to discourage safe personal drug importation through online pharmacies are less goofy than the above example but unfortunately they can be quite effective. FDA’s administrative actions further the pharmaceutical industry’s commercial goals of wiping out the competition – low-cost, safe, and reputable international online pharmacies. Such actions include public education campaigns that scare Americans away from safe and affordable medication, and endorsing non-profit groups – such as by attending their conferences – run by the pharmaceutical industry, ones that misinform the public and Congress about online pharmacies.
The FDA also granted a contract to LegitScript.com, a company that seeks to discredit reputable non-US online pharmacies and works with pharmaceutical industry stakeholders in the Alliance for Safe Online Pharmacies to lobby the White House and congress to initiate policies and pass legislation dedicated to doing away with safe international online pharmacies. With LegitScript.com receiving $2.6 million dollars in taxpayer money should it also be a leading member of an industry group that promotes the commercial goals of its core members, large pharmaceutical companies and U.S. pharmacies? This contract is indicative of the same collusion Dr. Paul speaks about: FDA using taxpayer money to fund a company that leads a lobbying group funded by pharmaceutical companies!
Congressman Paul’s idea to get rid of the U.S. Food and Drug Administration altogether goes too far. We need and are fortunate to have a strong drug regulatory authority to protect Americans from bad food and medicine. And we must recognize that the FDA is not always in cahoots with the pharmaceutical industry, and sometimes the U.S. government cracks down against pharmaceutical companies when they violate drug marketing laws, intentionally bring to market substandard medication, and withhold or misrepresent research data to hide negative effects of their approved medication.
On the other hand, Congressman Paul’s central criticism that the pharmaceutical industry too often pulls the strings of FDA policy in their pursuit of monopolistic goals to thwart competition and to the detriment of consumers appears to be right on the money when it comes to personal drug importation and online pharmacies. PhRMA and FDA cite safety concerns as the reason all non-US online pharmacies should be avoided. However, a recent study published by the National Bureau of Economic Research (NBER) clearly shows that properly verified non-U.S., international online pharmacies require a prescription and sell safe medication. Such online pharmacies enable Americans to afford needed prescription drugs that would otherwise be unaffordable in the United States. The report politely criticizes the FDA by stating, “that a blanket warning against any foreign website may deny consumers substantial price savings” from verified non-US online pharmacies.
We recognize that the FDA’s policy is not strictly a product of its relationship with the pharmaceutical industry. After all, importing medication for personal use is technically illegal, though unenforced. But the FDA is allowed and does use its administrative discretion to use common sense in its enforcement policies. Just recently the FDA allowed for the importation of prescription medication that is not technically approved for sale in the United States due to shortages of identical products approved for sale here. Such importation is technically illegal but the FDA affirmatively permitted it so that Americans could get the medication they need. And even when a drug is priced too high, which was the case with Makena the FDA has stepped in to allow low-cost, unapproved, compounded versions of that drug to be sold in the U.S.
With the ability to take the steps mentioned above, the FDA is certainly able to update the consumer content on its website to greater reflect he truth about non-US online pharmacies, as recommended by the authors of the NBER study. If the FDA is concerned about the drug shortages and high prices of Makena, then it should view as a national emergency the fact that 48 million Americans don’t fill prescription each year due to high prescription costs (See table 5, page 36). There are three specific steps the FDA could take to allow, or at least not prevent, limited and safe personal drug importation:
I. Revise and improve the accuracy of consumer information found on the FDA’s website, as it pertains to buying medications online and from online pharmacies.
II. As a matter of public health, revise FDA’s personal drug importation policy to explicitly disallow government officials from seizing personally imported prescription orders destined for Americans that they know are genuine and dispensed pursuant to a prescription – SEC. 801. [21 USC §381]; Section 9.2 of the FDA Regulatory Procedures Manual Imports and Exports
III. Ban enforcement actions against foreign companies known to operate safe international mail-order pharmacy practices and websites – SEC. 801. [21 USC §381]; Section 9.2 of the FDA Regulatory Procedures Manual Imports and Exports
These recommendations are fully explained in our submission to the FDA in responding to its request for comments.
Congressman Ron Paul introduced a bill to legalize drug reimportation through online pharmacies – the Prescription Drug Affordability Act – to help Americans access safe lower priced medicines. Passage of this legislation is unlikely anytime soon. The legislation, however, is not needed. The FDA can immediately take action to help Americans looking online for lower priced medication from other countries by pointing them to verified online pharmacies and away from rogue sites. With the proven existence of safe international online pharmacies, regardless of their potential technical legal violations of federal and state law, we have a source of safe and affordable medications, which Americans need to stay healthy or alive. In contrast, enforcement actions against safe international online pharmacies, which will deny Americans access to this lifeline, would simply be bad for the public health.
As it applies to personal drug importation and online pharmacies, Ron Paul’s libertarian school of thought triumphs. The FDA should not overregulate to the extent that it prevents Americans from getting their medication safely online. Millions of Americans who go without medication need the FDA to get this right. Less important, it would also demonstrate its greater independence from the pharmaceutical industry.
