Drug Prices

New Section 804 Drug Import Rule Does Not Allow Foreign Versions of FDA-Approved Drugs

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The new federal rule on drug importation from Canada, drafted pursuant to Section 804 of the FDCA, does not allow for the importation of foreign versions of FDA-approved drugs. It only allows for the importation of FDA-approved drugs. I’m writing this in response to a paper written by Thomas J. Bollyky and Aaron S. Kesselheim called “Reputation and Authority FDA and the Fight over U.S. Prescription Drug Importation.” Some people who read their paper may be confused.

Kesselheim and Bollyky assert that there are “three avenues for legal importation of prescription drugs that are not FDA approved.” The first example is personal drug importation, the second is importation from Canada under the new federal rule, and the third is shortages. I will address the second. 

By “not FDA approved,” they must mean foreign-versions of FDA-approved drugs. After all, the law only allows for the sale of FDA-approved drugs within the United States. The new importation rule doesn’t change that basic fact.

In September, the Department of Health and Human Services (HHS) issued a new rule allowing for the importation of lower-cost prescription drugs from Canada, subject to many restrictions. Restrictions mostly prevent controlled or biologic drugs from import under the new rule. But do they also prevent “foreign versions” of FDA-approved drugs?

A drug is considered “FDA-approved” when the FDA approves the drug application of a manufacturer to market that drug in the United States. Kesselheim and Bollyky write:

“FDA approvals are specific to the information in the NDA or ANDA, including: the manufacturer, product, and its use; manufacturing location, formulation, source, and specifications of active ingredients; processing methods; manufacturing controls; labeling; and appearance.”

A foreign version of an FDA-approved drug is a finished pharmaceutical that has the active ingredient contained in the FDA-approved version and is approved in another country. That foreign market approval may be a drug that works just as well as the FDA-approved version, but it’s still not considered FDA-approved. Why?

  1. It’s a different formulation. FDA-approved Nexium is sold as a capsule; whereas European versions of Nexium are in tablet form: those are foreign versions of FDA-approved drugs.
  2. It was made in a plant that is not registered with the FDA for making that specific drug. An example is Daraprim (pyrimethamine), the drug made famous by Martin Shkreli for hiking its price from $13.50 to $750 a pill overnight. FDA-approved Daraprim is made in the U.S. The Daraprim sold in the UK for example is made in Europe by GlaxoSmithKline. It might be the exact same drug, including formulation, but GlaxoSmithKline did not apply to market the drug made in Europe in the U.S. That, too, is a foreign version of an FDA-approved drug, but much cheaper at about 5 bucks a pill in the UK.
  3. There’s a different inactive ingredient. In this case, a drug sold in Canada carries the same active ingredient and formulation as an FDA-approved drug. But the Canadian drug includes a different binder or filler as inactive ingredients. The Canadian drug is now deemed a foreign version of an FDA-approved drug.

Those examples of foreign versions of FDA-approved drugs cannot be sold inside the U.S. The new HHS rule states:

“To be eligible under the final rule, a drug needs to be approved by the Government of Canada’s Health Canada’s Health Products and Food Branch (HPFB) and, but for the fact it bears the HPFB-approved labeling when marketed in Canada, needs to otherwise meet the conditions in an FDA-approved new drug application (NDA) or abbreviated new drug application (ANDA). Essentially, eligible prescription drugs are those that could be sold legally on either the Canadian market or the American market with appropriate labeling.”

In other words, the drug must be an actual FDA-approved drug except for the labeling.

Kesselheim and Bollyky go on to propose and advocate a system of allowing the safe importation of high-quality foreign versions of FDA-approved drugs to tackle the price gouging on off-patent medicines. It’s a great plan!

Related: A Drug Importation Vocabulary Lesson: Misbranded and Unapproved Drugs

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It Takes a (Global) Village to Manufacture Merck’s Proventil Inhaler

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Importation of prescription drugs to help lower prices for Americans will remain a major issue no matter who is president next year. The more we know about where our meds are made (mostly not here) the less successful drug industry lobbying will be against lower-cost, imported medicines.

In some cases, it’s as simple as a drug sold at a U.S. Walgreens is made in a manufacturing facility in one foreign country. For example, type 2 diabetes drug Jardiance (empagliflozin) is made in Italy. Another drug that treats type 2 diabetes, Januvia, is a little more complicated. Its active pharmaceutical ingredient (API) is made in Italy, but that API is formulated into the finished drug in the UK.

Last year, Par Pharmaceutical, a subsidiary of Endo International PLC, began shipping authorized generic versions of Merck’s Proventil (albuterol sulfate), an HFA inhalation aerosol.

In a class of medical products called bronchodilators, Par’s albuterol sulfate provides fast breathing relief for people with asthma and COPD (chronic obstructive pulmonary disease). Where’s it made? Three countries have a hand in making it. More specifically, different aspects of its production occur in three countries. Here’s what the label says:

Manufactured for Par Pharmaceutical, Chestnut Ridge, NY 10977, U.S.A.

Developed and manufactured by: 3M Drug Delivery Systems, Northridge, CA 91324, U.S.A.

Albuterol Sulfate (active ingred.)

Made in Italy

Formulated in USA

Actuator made in USA

Dose Indicator Made in Canada

That’s a mouthful!

As it happens, Par’s generic Proventil is quite affordable in the U.S., at least with a discount coupon. Checking on GoodRx, the generic Proventil price is one inhaler for $16.91, which is comparable to the price at Canadian and other international pharmacies. The lowest listed price on PharmacyChecker is around $45 for three generic inhalers.

In the coming months, followers of this blog will be learning more and more about drug supply chains. In the meantime, let’s continue to come together on the importance of lowering drug prices in America.

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My Quick and Dirty Take on Trump’s Drug Price Efforts

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Photo courtesy of WhiteHouse.gov

I’m a Democrat and voting for Joe Biden. It’s good to be honest. Biden supporters may view my blog post more favorably, while Trump supporters might be more skeptical. I can live with that. You can all fact check me. But ask yourselves: “have my prescription drug costs gone down over the past four years”? If you want to respond in the comments, please do so politely. About 25% of Americans, many tens of millions of people, say they have a hard time affording their meds.  As I mention below, we should all get along on this issue. It’s not only critical that we end the madness of high drug prices in America, but let’s unify when we agree!! 

My quick and dirty position point here is that most of Trump’s efforts to lower drug prices have either failed and/or are simply political window dressing to help him get elected. Before my fellow Democrats turn up your noses, just know that Obama promised to take on Big Pharma, too, but he did not. For a positive spin, Trump’s bashing Big Pharma rhetoric may have future political reverberations on the Republican party in favor of real actions to lower drug prices.

Trump said before and after his inauguration that the drug companies were “getting away with murder” and that prices would come “way down”. Source: https://khn.org/morning-breakout/pharma-is-still-getting-away-with-murder-trump-says-hinting-at-intent-to-bring-down-costs/

I’m sorry, America: Drug prices remain exorbitantly high. They don’t have to be. So many issues divide our country. Not this one.  Republican and Democratic voters overwhelmingly agree that drug prices are too high, on legislative and policy reforms to fix the problem. Case in point: 80% of Republicans and 90% of Democrats believe that Medicare should be allowed to negotiate with drug companies for lower drug prices. On drug importation, 76% of Republicans and 78% of Democrats support it. [Source: Kaiser Family Foundation]. Where else is there such bipartisan unity these days? 

As founder of Prescription Justice, a non-profit and non-partisan organization, I’m trying to make lowering drug prices an advocacy efforts that really brings us all together. Please come check out what we’re doing! 

Look, Trump has claimed “Drug prices are coming down, first time in 51 years because of my administration.” There are tiny pebbles of  truth here. PolitiFact rates this claim Mostly False. It’s a good analysis. The gist is that threats by Trump may have slightly slowed increases among the big companies but nothing substantive was accomplished. 

Trump’s famous executive orders on drug prices of this past summer have not lowered drug prices but were the stuff of reality TV. He would argue to give him time but why did he wait until the last year of his administration, just as his campaign was kicking into 5th gear to take these actions? 

With one of his executive orders, Trump opened up the policy door to expand drug importation – but there’s vast leeway to shut that door quickly. I wrote about the executive order on Ask PharmacyChecker and specifically about what we could hope for if Biden wins to keep moving forward on importation. 

I strongly believe that a Biden administration would enact policies to lower drug prices in a manner equally satisfying to Republicans and Democrats. I realize that drug prices aren’t the only issue. But when the election is over, let’s come together and end the crisis of high drug prices in America.

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Rep. Schakowsky (D-IL) Gets an A+ on Drug Prices in Congressional Report Card

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This post was originally published on Prescription Justice.

The highest score in the Prescription Justice Congressional Report Card on Drug Prices – 100 – goes to Representative Jan Schakowsky (D-IL), with a grade of A+. The only other A+ in the House goes to Rep. Perter Welch (D-VT), who landed a score of 99.5.

In simple terms: Rep. Schakowsky gets the high score because she was incredibly committed, active and vocal about lowering drug prices – and barely takes money from drug companies: just over $1000. If all members of Congress hopped on the drug price lowering bandwagon just like Rep. Schakowsky, the crisis of high drug prices in America would end.

More specifically, Rep. Schakowsky had a perfect voting record (30 of 30 points), sponsored or co-sponsored 17 bills (25 of 25 points), gave priority on her congressional website to drug prices (20 of 20 points), and only took $1,134 from drug companies in campaign contributions (20 of 25 points).

You’ll notice that the only scoring criteria on which she lost points was campaign contributions from drug companies. We admit it: we’re very strict about that. But in the case of members like Rep. Schakowsky, the numbers are miniscule and obviously have not shaped the Congresswoman’s policies on drug prices.

You may also notice that Rep. Schakowsky’s raw score is a 95. Since she received the highest raw score, it was used as a benchmark for all other scores: hence the curve was 5 points to make 100! If you want to learn more about how Prescription Justice grades members of Congress, House and Senate, click on the chambers to view the methodologies.

Or, for more fun, watch the video on the Prescription Justice Congressional Report Card on Drug Prices.

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Trump administration surrogate says you can buy cheaper meds from Canada

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A surrogate for the Trump campaign, Katy Talento, stated in an interview with Elisabeth Rosenthal, Editor-in-Chief, Kaiser Health News, that personal drug importation is allowed as a means for Americans to afford prescription drugs. I bring this up to make two points:

One, to remind the reader about the legal basis for the non-enforcement policy.

Two, to point out that during the Trump administration, the FDA has actually increased the numbers of prescription drug orders from other countries that it seizes, flouting the non-enforcement policy.

Ms. Talento’s remarks came in the form of an answer to a question that Ms. Rosenthal asked on behalf of Mike from Louisiana. Mike stated that he and his wife get their meds from Canada because they cost 50-75% less. Trump has been raging about drug prices for four years, but when are they going to see savings on their U.S. pharmacy shelves? Start at minute 42:00 in the video below.

The key remark by Ms. Talento is as follows:

“I’m so grateful that we have a policy of non-enforcement around…individual importation from Canada so that folks like Mike and his wife in Louisiana can continue doing what they are doing.”

Wrongly, the FDA has stated that – while the agency won’t pursue individuals for prosecution – it cannot simply allow personal imports so that Americans can afford medications. That’s not true. The law states:

“[the FDA] should exercise discretion to permit individuals to make such importations in circumstances in which (i) the importation is clearly for personal use; and (ii) the prescription drug or device imported does not appear to present an unreasonable risk to the individual.”

See: 21. U.S.C. 384(J)

One could counter that the law says “should” not “must,” but that doesn’t mean the FDA “cannot.” Others might point out that people are allowed to import, but only by physically bringing back a prescription drug from Canada. Not true. In this case, the questioner is from Louisiana. He doesn’t travel to Canada but probably orders his and his wife’s medications from a safe international online pharmacy. The law on personal importation cited above does not prevent mail order imports in any way.

This is not academic. Despite the Trump administration’s bullishness on drug importation, via executive orders, administrative Section 804 rule-making, and request for proposals on importation, the FDA has actually ramped up refusals and destructions of personal drug imports even when they “should” be allowing them.

Read Kaiser Health News: Amid Pandemic, FDA Seizes Cheaper Drugs From Canada

When we’re past this national nightmare next year, let’s get this right. It’s time to fully permit, not just allow through “enforcement discretion,” safe personal drug importation.

I disagree with Donald Trump on 95% of his policy decisions for the United States, but I like the 5% that relate to prescription drug importation.

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HHS Insulin Import RFP Misinterprets the Law: Reimportation vs Importation

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There is no end to my fascination over the new authorized pathways for wholesale and personal importation of lower cost drugs from Canada and many other counties. Last week, I wrote about the request for proposals from HHS on personal drug importation; the week prior, about the certification of Section 804 for wholesale imports from Canada. Today, I’m going to get very, very nerdy about the new Request For Proposals issued to allow for the reimportation of insulin. I am not sure the government could get more obtuse than this in trying to pretend to help people with importation while making it exceedingly difficult and limited.

Unlike the final rule on Section 804 of the FDCA and personal importation pathway opportunities also under Section 804, the Insulin RFP relates to Section 801(d)(1)(2) of the FDCA (21 U.S.C. 381). Veterans of this policy debate would recall this as the statute banning reimportation of prescription drugs. Notice the “re” is underlined.

From 1988 until 2017, Section 801(d), called “Reimportation,” banned any importation of a drug manufactured in the U.S., then exported, from being imported – or reimported – except by the manufacturer of that drug. The only exception, found in 801(d)(2), was if the Secretary declared that importing a drug is “required for emergency medical care.”

In 2017, 801(d), was amended to ban the importation of foreign made FDA-approved drugs for commercial distribution, except if the manufacturer authorized it. Many people had thought that ban was in place from 1988-2017 on imported (not just reimported) drugs. It was not. Presumably, they added it to prevent people and companies – other than the manufacturers – from importing FDA-approved drugs at much lower prices and re-selling them. The amending language, however, did not ban imports for personal use, just re-sale.

As an aside: that change to the law took me by surprise. Pharma just sneaks stuff into bills any old time they want to. I wrote about it earlier this year.

Flash forward to the new Insulin RFP. Long story, short: HHS will allow the reimportation of insulin by entities other than the manufacturer based on a determination that it’s “required for emergency medical care” as called for in 801(d)(2). It specifically does not allow importation of FDA-approved insulin made elsewhere to be imported! Remember, these are drugs that are already imported by the drug companies themselves. The three major insulin products in the U.S. are Lantus (Sanofi), Humalog (Lilly) and Novolog (Novo Nordisk). Guess what. The Lantus and Novolog sold at U.S. pharmacies are made in Germany and Denmark, respectively. That leaves only Lilly’s Humalog for possible reimportation at lower cost because it is in fact made in Indiana. It is notable that Lilly’s former USA president is the one issuing this RFP: HHS Secretary Alex Azar. What a coincidence.

The crazy thing here is that it appears the authors of this RFP forgot or are ignoring the 2017 amendment to the statute.

The RFP states: “the statutory exception in section 801(d)(2) of the FD&C Act does not apply to insulin products manufactured outside of the United States.” That may have been true in 2016, but not anymore. Let us look the statute, as amended of course:

“(d) Reimportation

(1)(A) Except as provided in paragraph (2) and section 384 of this title, no drug subject to section 353(b) of this title or composed wholly or partly of insulin which is manufactured in a State and exported may be imported into the United States unless the drug is imported by the manufacturer of the drug.

(B) Except as authorized by the Secretary in the case of a drug that appears on the drug shortage list under section 356e of this title or in the case of importation pursuant to section 384 of this title, no drug that is subject to section 353(b)(1) of this title may be imported into the United States for commercial use if such drug is manufactured outside the United States, unless the manufacturer has authorized the drug to be marketed in the United States and has caused the drug to be labeled to be marketed in the United States.

(2) The Secretary may authorize the importation of a drug the importation of which is prohibited by paragraph (1) if the drug is required for emergency medical care.”

Do you see Section (2) right above? The Secretary can allow imports of drugs otherwise prohibited by paragraph (1) for emergencies. Before 2017, paragraph (1) was just (A) but notice there’s a (B). I know it is separated by paragraph in this block quote – but the statute says “paragraph 1” not the first paragraph or, paragraph (1)(A). Moreover, (2) refers to authorizing the importation of a drug – not the reimportation only of a drug.

The law is not ambiguous. Lantus and Novolog can be exempted for importation under this part of the statute and of course they should be.

You might ask if this even matters—this is all Trump window dressing anyway.

It does matter.

Even if they are making it difficult, they have opened the door to importation of more affordable prescription drugs. While we pursue longer-term legislative reforms to lower prices here, let’s use what we’ve got to get people access to insulin at much lower cost as fast as possible! I will leave you with a quote about insulin costs from the RFP:

“Americans pay significantly more for insulin than patients in other countries do. A recent HHS commissioned study found that the average gross manufacturer price for a standard unit of insulin in 2018 in the United States was more than ten times the price in a sample of 32 foreign countries. This cost differential presents an opportunity to pass savings onto Americans who are struggling to afford this life-saving medication. The high price of insulin and the corresponding potentially dire health consequences from rationing has become an emergency, particularly since the number of Americans diagnosed with diabetes continues to rise.”

Amen.

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FDA opens door to expressly permit personal drug importation, and yet…

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Americans have been personally importing medications for decades. In most cases, the reason is that the same drugs sold in the U.S. are much cheaper elsewhere. According to a recent JAMA article, about 2.3 million Americans import drugs to save money each year. The Kaiser Family Foundation pegged the number at about 20 million, total. This, despite the fact that, under most circumstances, such imports are prohibited. As explained below, under an executive order and a request for proposals by the U.S. Department of Health and Human Services and Food and Drug Administration (HHS/FDA), the door has been opened to formally allow personal drug importation, but the proposed parameters of the RFP ignore greater opportunities, savings and the law itself.

First, wholesale importation of lower cost drugs from Canada is now lawful. That is pursuant to Section 804 of the Food, Drug and Cosmetic Act. Such wholesale importations had been prohibited because the HHS Secretary had yet to certify that the importation would cause no additional public health risk and result in substantial savings for Americans. That certification, as required in Part L of Section 804, was provided by Sectary Azar last week.

Unlike wholesale importation, Section 804 does not legalize personal importation from Canada or other countries, but it does permit it through enforcement discretion, regulation or waiver. Currently, personal drug imports are often permitted through enforcement discretion. A recent executive order on drug importation asked the Secretary to expressly permit personal importation to help Americans afford prescription drugs. I was skeptical that HHS would actually move forward and act on the executive order. It has moved forward but appears to be ignoring one part of the law that would most help people immediately.

Last week, HHS/FDA published a request for proposals on granting waivers that can expressly permit individuals to import lower cost prescription drugs for personal use. This authority is granted by Section 804(J2) of the Food, Drug and Cosmetic Act. The RFP states:

“Under the programs described herein, the Secretary may grant waivers to individuals who seek to import prescription drugs for personal use. Under these programs, the individual will obtain the imported prescription drugs from an authorized State licensed pharmacy through an authorized IWIP [Individual Waiver Importation Plans].”

I’m excited about this new opportunity for prescription drugs savings, but the proposal does not reflect the reality of how personal drug importation helps Americans save the most money. They do so by buying directly from pharmacies in other countries. There are no middlemen. Purchases are made in person, whether in Canada, Mexico or another country; over the Internet from online pharmacies; “storefronts,” essentially offices where people go for help ordering medication internationally, or through international pharmacy benefit programs offered by self-insured entities, such as unions or municipalities.

The RFP does not authorize the aforementioned activities. It states:

“This pathway would not authorize individuals in the United States to purchase prescription drugs through the Internet, directly from a foreign pharmacy, or from any other foreign seller.”

The RFP requires that the imported drugs be dispensed in a U.S. pharmacy. The parameters impose a sort of hybrid of wholesale and personal importation. Personal importation is directly importing from a pharmacy in Canada. Wholesale importation is when a U.S. company, such as a wholesale pharmacy or retail pharmacy imports commercial quantities for re-sale. The RFP states:

“For the Secretary to issue a waiver for an IWIP drug, the plan sponsor, which may be any interested person (including a distributor, wholesaler, or pharmacy) would submit to the Secretary an application identifying the specific FDA-approved prescription drugs that individuals would be able to import.”

Per those parameters, the RFP creates an unnecessary intermediary, and reduced savings. Clearly, a commercial wholesaler that participates will expect a profit. Importing the drugs and distributing them to a retail pharmacy cost money. The retail pharmacy will also take a cut of the sale. From a savings viewpoint, this is not optimal, and the law doesn’t require it either.

Part J envisions and calls for Americans buying their own medications directly from pharmacies in other countries, singling out for special treatment Canadian pharmacies. Additionally, the essence of that section pertains to enforcement discretion to permit personal imports that do not represent an “unreasonable risk” to the public health. Per J(1), this enforcement discretion should be permitted for FDA-approved drugs and foreign versions of FDA-approved drugs. J(2) allows the Secretary to grant waivers and create specific regulations, as is the case with this RFP. But that allowance does not negate J(1)’s direction, which the Secretary is ignoring.

Another example of how HHS is ignoring the law is with J(3). J(3) instructs the Secretary to allow direct personal imports from Canadian pharmacies. The law is clear and yet this is not being done.

Finally, this RFP goes beyond the requirements of the law in stating that waivers will be granted to allow personal imports that “will pose no additional risk to the public’s health and safety and would result in a significant reduction in the cost of the covered products to the American consumer.” The standard in J(1) is that the import should not pose an “unreasonable risk.” FDA regulated personal drug importation is a great step in the right direction. However, those Americans who choose to and— more critically – need to import their medications directly should do so from pharmacies in other countries (as they do already despite it being prohibited). HHS/FDA has an opportunity and responsibility to provide the American people with consumer guidance to help them do so safely.

It’s worth noting that the RFP doesn’t rule out what I’ll call real personal drug importation. It specifically states it does not authorize Internet purchases. It’s conceivable that a well-articulated proposal to allow waivers to patients who want to get their medications in Canada could be successful, either through this RFP process or other processes, such as a Citizen Petition.

For what it’s worth, this new RFP pushes the envelope in the right direction, but greater pushing is needed so that Americans more quickly get the prescription drug price relief they need. That includes buying the medication and receiving it from a Canadian pharmacy via the Internet.

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Hoping Trump’s Florida Drug Importation Politics Helps Patients Under Biden

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Well, as I was writing this post about the politics of importation, the FDA published its final rule on drug importation. Find it here: Section 804 Final Rule. It’s 179 pages so I haven’t had time to read it all yet.

As a quick reminder, pursuant to Section 804 of the Food, Drug and Cosmetic Act, the FDA issued a proposed new rule to allow wholesale imports of lower-cost drugs from Canada, subject to many conditions and excluding expensive biologics. Phillip Galewitz of Kaiser Health News asks if this is an “election gift for Florida” reporting that Florida will be the first state granted approval to import by the FDA. This is not surprising. Florida has an exceptionally large number of retired, older Americans who are unhappy about the cost of prescription drugs and 29 electoral college votes that Trump cannot afford to lose.

The Secretary of Health and Human Services has now certified no additional safety risks and the realization of substantial savings from importing lower cost drugs from Canada, under certain conditions. But the rule states that personal importation provisions are not in effect. Really?! Maybe they want to write a new importation law without Congress. These days, who knows what might happen? Arguments were made even before the certifications of safety and savings by the Secretary, the personal drug importation provisions protected personal drug imports. As I see it, now that Section 804 in its entirely is in effect, personal importation is more expressly permitted than before.

The FDA’s rule on Section 804 describes the conditions under which eligible entities in the U.S., such as states and their designated wholesalers, can import lower cost drugs from Canada. There is a lot of debate about how much this can actually help with drug prices. It’s no secret that I am a staunch supporter of drug importation to help end the stranglehold Big Pharma has on the American people – even though it is just one policy tool in the shed – but even I believe that this limited opening of the door to wholesale imports might be of little help. Here are three primary reasons:

One, Canada is too small of a country for largescale importation and the Canadian government is not psyched at the prospect of the U.S. siphoning off their drug supplies.

Two, if you read the rule, it makes it easy for drug companies to restrict supplies to pharmacies in Canada so that they do not get into this market.

Three, Section 804 excludes biologic drugs from the list of possible import. Biologics, medical products derived from living organisms, are much more expensive than regular drugs.

Even with those limitations, I support this final rule to allow states to proceed with trying to use importation from Canada to ease cost burdens. It can help. We will just have to see how much. What may be more important is that the rule and policy momentum in favor of importation help debunk the myth that drug importation is not safe. It is safe. Expanding beyond Canada, through further legislative and regulatory reforms to Europe and Japan, is the way forward. That would work to bring down drug prices dramatically.

I submitted public comments regarding the drug importation rule back in March urging the FDA to open the door further to personal (not just wholesale) importation. For years, without this express permission under law, millions of Americans have already been benefiting from buying drugs internationally from licensed pharmacies in other countries. My public comments gave specific steps the FDA could take to help more Americans benefit. I started this blog post reporting what the rule states on personal importation and my belief that the rule leaps far beyond what the law allows for! Reminder: the FDA, according to Section 804, which is in effect, should allow personal importation. I’ll take this further next week.

I have to add for posterity: I hope to God that this drug importation momentum carries over into a Biden administration next year. Biden will hopefully bring other policy tools to the table to lower drug prices, not to mention saving our nation’s democracy…

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Explaining Rep. Pelosi’s F Grade on Drug Prices

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Originally published on PrescriptionJustice.org

Prescription Justice has graded all members of Congress in a drug prices report card. Some people are dismayed that Speaker Nancy Pelosi received an F. After all, didn’t she roll-out and shepherd H.R. 3, the Elijah Cummings Lower Drug Costs Now Act, through the House and vociferously called for its passage on the House floor, as read on the Speaker’s website. So, what happened to her grade? A lot of Rep. Pelosi’s F has to do with her role as Speaker and how it differs from all other legislators.

I admire Speaker Pelosi for many – even most – positions she’s taken and advanced throughout her career – including her work to pass H.R. 3. Not surprisingly, I’m a Democrat! But that cannot change the math of our system of grading.  

Due to the methodology and quantitative factors used to create the report card, even a vocal advocate like Rep. Pelosi, can get an F. You see Prescription Justice grades objectively on the following factors: 1) votes; 2) bill sponsorships/co-sponsorships, 3) campaign contributions from drug companies; and 3) policy positions articulated on member’s websites.

In the case of Rep. Pelosi, as with all members, it comes down to action (or the lack thereof). Rep. Pelosi did not vote for H.R. 3 and another drug pricing bill assessed as part of the grade. She also didn’t sponsor/co-sponsor any bills to lower drug prices. She accepted some hefty contributions from pharmaceutical manufacturers and her congressional website was void of any positions on policies to lower drug prices.

Let me repeat, Rep. Pelosi did not vote for H.R. 3. She also did not sponsor or co-sponsor the bill. I’m told that Speakers of the House refrain from certain votes and co-sponsorships of bills and that’s the reason. I respect that. But the methodology that Prescription Justice uses is objective and quantitative and we did not create a carve out for Speakers. In the future, perhaps we can devise an objective method for doing so.

Whatever your thoughts on this, don’t judge the card based on Pelosi’s F. There are 534 other members of Congress. If you look at the rest of the grades, I believe you’ll find that where this one may seem wrong on the surface, you’ll find almost all the others accurately show who is most active and committed to lowering drug prices. For example, would anyone argue that Rep. Jan Schacowsky should get an A+ or that Rep. Doug Collins should receive an F? Go take a look.

Let’s get these grades in front of voters to show them accurately who’s standing up to the drug companies and who’s carrying their water. 

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Valisure Supports Drug Importation | PharmacyChecker Blog

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Valisure is a U.S. online pharmacy that actually tests the quality of medication it sends to patients and apparently, to my delight, they support drug importation as a policy to lower costs. Pretty cool.

When people go online or to their local Walgreens to buy prescription drugs domestically, they are largely relying on the regulatory strength of the U.S. Food and Drug Administration to make sure those drugs will work as directed by their prescribers. While the FDA is known as a top drug regulator, for all intents and purposes, Valisure is saying that you can’t fully trust them. Why? Because they don’t do adequate testing to prove safety and effectiveness of drugs. Furthermore, the agency’s position that FDA-approved generic drugs work just as well as the brand is often not true.

Indeed, according to Valisure, not all FDA-approved generic versions of brand drugs are created equal. However, if you buy a prescription drug from Valisure, the company claims to conduct testing beyond what the FDA requires that will better ensure its safety and efficacy. I wrote “claims,” but I believe them! Really, it comes down to independent and more rigorous testing. But what does that have to do with drug importation?

David Light, the founder and CEO of Valisure, testified before the Senate Finance Committee about drug safety and quality, and relevant regulatory shortfalls. Importation was not a focal point. The focus was on problems with the FDA’s reliance on inspections of drug manufacturing plants and drug companies telling the truth about their safety data. That’s not good enough, says Mr. Light. Test, test, test was the mantra of the testimony. At the end of the testimony, Mr. Light stated:

“Finally, another avenue where independent batch-level validation of drugs could easily be applied is drug importation. Drug importation is a unique opportunity to reimagine the drug supply chain and rebuild it in a way that helps ensure drug quality by incorporating independent chemical analysis of all imported products – essentially making all imported drugs certified drugs. We believe that drug importation is not only an important opportunity to provide lower-cost drugs to American consumers, but to enable even higher quality assurance than is presently possible in the current domestic drug supply.”

Importation leading to lower cost and higher quality drugs. What an idea!

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