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The recently signed appropriations or “omnibus” bill to fund the federal government includes an additional $94 million (Section 778) for the FDA to screen and stop drug imports at international mail facilities (IMFs). That could mean fewer people receiving their prescription medications that they have ordered from Canadian or other international pharmacies.

As I wrote a couple of weeks ago, the FDA’s coming crackdown against opioids could be a cover for greater import refusals and destruction of imported medications. This new appropriation of $94 million is a lot of money. In the case of drug importation, that money could be used for good (intercepting opioid ingredients en route to drug dealers or addicts) or evil (refusing and destroying prescribed medication en route to a patient who can’t afford the drug here).

You can read the section of the bill showing the appropriation and what it’s for at the end of this post. It states that the money is for “necessary expenses of processing opioid and other articles imported or offered for import through international mail facilities of the U.S. Postal Service.” Those “other articles” include prescription medications from pharmacies in Canada and other countries. Since the FDA considers those imports illegal, at least under most circumstances, it can refuse them and even destroy them – but must first alert the patient who ordered them giving them due process to defend their prescription order.

Late last year, in reporting from Kaiser Health News about an FDA crackdown against offices in Florida that help people buy more affordable imported medications, reporter Phil Galewitz initially wrote that that FDA Commissioner Scott Gottlieb stated in a speech that:

“The agency would be stepping up its work to prevent the importation of drugs into the United States, including tripling the workers at international mail facilities who inspect packages suspected of containing drugs.”

You can read that in the Washington Post version of Mr. Galewitz’s article.

However, in the article currently published on Kaiser Health News, it states:

“Update: This story was updated on Nov. 20 to remove a quote from a recent speech by FDA Commissioner Scott Gottlieb. His comments were a reference to stopping opioids from coming across the border, not all prescription drugs.”

Legally, the new infusion of funds to stop imports is not limited to just opioids or even controlled drugs (like Vicodin, Valium, and Adderall). In fact, the language employed by the FDA to discuss enhanced enforcement at IMFs encompasses all types of prescription drugs. A recently published FDA document about IMFs states:

“The IMFs receive international mail from more than 180 countries, which often lack advanced manifest data that would aid in targeting shipments that are likely to contain illegal, illicit, unapproved, counterfeit and potentially dangerous drugs.”

What does “illegal, illicit, unapproved, counterfeit and potentially dangerous drugs” mean?

Clearly, we want to stop counterfeit drugs but what about the others? Any drug you buy at CVS, Walmart, Walgreens, etc. is “potentially dangerous”. Unapproved drugs anybody? Remember Martin Shkreli, the guy in jail for securities fraud who hiked the price of Daraprim from $13.50 to $750 overnight? It’s still about $750. A “foreign unapproved version” like the one made by GlaxoSmithKline and sold in the UK for $6/pill could be refused and destroyed by the FDA with some of that 94 million bucks.

See: Drug Importation Vocabulary Lesson.

Earlier this week, Sen. Lamar Alexander (R-TN) introduced a draft of a bill dedicated to affecting how this $94 million is spent. Here’s the press release. The headline is:

Alexander: Draft Legislation Would Require Dispensing Opioids in Short-Term Blister Packs, Help FDA Stop Illegal Fentanyl at Borders

Fine. Write a rule of construction in the bill to clarify that its target is opioids and other addictive drugs – not lawfully-manufactured medications being mailed to patients who need them.

Americans are angry as hell because they can’t afford medication here. Eighty percent believe drug prices are unreasonable. Don’t take their meds away. I believe that FDA Commissioner Scott Gottlieb wants to stop illegal and dangerous opioid drugs from coming in to our country. But I also believe he may be willing to take away medicines that Americans have purchased from pharmacies outside the U.S. I’m not sure. Let’s hope he has the power and compassion to prevent that.

 

FROM H.R.1625 – Consolidated Appropriations Act, 2018

Sec. 778.  For an additional amount for “Department of Health and

Human Services–Food and Drug Administration–Salaries and Expenses”,

$94,000,000, to remain available until expended, in addition to amounts

otherwise made available for necessary expenses of processing opioid

and other articles imported or offered for import through international

mail facilities of the U.S. Postal Service:  Provided, That such

additional amounts shall also be available for expanding and enhancing

inspection capacity related to such processing activity (including but

not limited to increasing staffing, obtaining necessary equipment and

supplies, and expanding and upgrading infrastructure, laboratory

facilities, and data libraries):  Provided further, That amounts

appropriated under this section shall be in addition to amounts

otherwise made available for research and criminal investigations

related to such import articles, and be available for enhancing such

research and investigations:  Provided further, That the Secretary of

Health and Human Services shall provide quarterly reports to the

Committees on Appropriations of the House and Senate on the obligation

of amounts appropriated under this section.

 

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