Below is a copy of Gabriel Levitt’s comments on the FDA Notice of Proposed Rulemaking titled “Importation of Prescription Drugs” that were submitted Monday, March 9th, 2020.
Comments on Notice of Proposed Rulemaking titled “Importation of Prescription Drugs, FDA-2019-N-5711, 84 Fed. Reg. 70796“
Docket No. FDA-2019-N-5711
Date: March 9,
Submitter: Gabriel Levitt, Co-founder and President,
PharmacyChecker; Founder and President, Prescription Justice
I appreciate the opportunity to comment on this notice of
proposed rulemaking (NPRM). Founded in 2002, and launching its website in 2003,
PharmacyChecker provides consumers with online pharmacy verification and
comparative drug price information to help them make the best decisions for
themselves and their families on how to afford prescription drugs.
On behalf of Prescription Justice, I submitted comments to
the FDA in response to its request for public comments on its draft guidance
of Certain FDA-Approved Human Prescription Drugs, Including Biological
Products, under Section 801(d)(1)(B) of the Federal Food, Drug, and Cosmetic
Act: Draft Guidance for Industry.”
I published the comments in their entirety on Prescription
Justice here: https://prescriptionjustice.org/resources/blog/opportunities-safe-personal-drug-importation-under-section-801-public-comments-prescription-justice.
I have a different story to tell here about the new, or
newish reimportation law.
(more…)Tagged with: reimportation
The FDA has drafted a proposed rule to facilitate wholesale importation of lower-cost drugs from Canada, pursuant to Section 804 of the Food, Drug and Cosmetic Act. Importation from Canada is legal under this section of U.S. law, but only if the Secretary of Health and Human Services (HHS) certifies, as stated in Part L, that such importation would pose “no additional risk” to the public and would help save the American consumer money. It’s a major milestone that the FDA is willing to and on the cusp of finally providing that certification – but that’s only for wholesale importation. What about personal drug importation? Wholesale drug importation is when people or companies import drugs for re-sale, usually described as commercial quantities. Personal drug importation is when a consumer fills a prescription in Canada or another country and imports it either carrying it across the border or through the mail.
Section 804, as clearly stated in Part J (1), treats
personal drug importation differently, and this is of paramount importance for
policymakers and the general public to understand. Section 804 doesn’t legalize
it across the board but affirms that Americans should be permitted to import
prescription drugs for personal use, as long as it doesn’t represent an “unreasonable
risk” to the patient. This more liberal standard is fundamentally
different from Part L of Section 804, which mandates “no additional risk”
to the public health, the standard necessary for the overall section to
become effective. Where does that leave us in terms of law and policy?
The following statement, recently published in the Congressional Record, was submitted by Gabriel Levitt on October 30, 2019, on behalf of PharmacyChecker and Prescription Justice, to the Committee on Ways and Means of the U.S. House of Representatives 116th Congress pertaining to a hearing entitled: “Investing In The U.S. Health System By Lowering Drug Prices, Reducing, Out-of-Pocket Costs and Improving the Medicare Benefit”.
“Investing In The U.S.
Health System By Lowering Drug Prices, Reducing, Out-of-Pocket Costs and
Improving the Medicare Benefit”
October 29, 2019
Co-founder and President, PharmacyChecker.com, 333 Mamaroneck Avenue, White Plains, NY 10605, 718-554-3067, email@example.com
Founder and President, Prescription Justice, 3309 Robbins Road,
#412, Springfield, Illinois 62704, firstname.lastname@example.org
Our company, PharmacyChecker.com verifies online pharmacies,
and compares drug prices among those accredited in our online pharmacy Verification
Program. Consumers, Americans and worldwide, access our website for free. Our
website has received about 30 million visitors since we launched our virtual
doors in 2003. Our niche is comparative pricing and the proper credentialing of
international online pharmacies, which process prescription drug orders filled
by licensed pharmacies in several countries, require valid prescriptions, and
do not ship controlled drugs into the U.S. We also provide information about
discounted U.S. pharmacy prices and patient assistance programs. The information we provide helps people make
the best decisions for themselves and their families when struggling with the
cost of prescription drugs.[i]
(more…)Tagged with: Congressional House Ways and Means Committee
The FDA has done something that prescription drug
importation advocates had possibly given up on. Not me. The agency drafted a new
proposed rule to allow importation from Canada of lower-cost drugs and industry
guidance for drug manufacturers to import their FDA-approved foreign drug
versions, for which they can charge lower prices. The proposed rule provides
specifics so that states contemplating or already formulating wholesale drug
importation programs have a shot at gaining approval for those programs, per
Section 804 of the Food, Drug and Cosmetic Act.
Year after year after year, the media has reported Pharma’s
talking point: No Secretary of Health and Human Services, Republican or
Democrat, has been able to certify the safety of importation from Canada.
That’s never been true, at least not exactly. It’s not that they haven’t been
able. It’s that they haven’t been willing. Also, it’s not just certifying the
safety, it’s certifying that there will be “no additional” safety risk – a high
standard. Well, apparently it can be done. The FDA stated:
(more…)Tagged with: Drug and Cosmetic Act
A new Chinese law (in effect as of December 1, 2019) makes third-party
online platform medicine sales legal, appropriately ends a draconian definition
of counterfeit drugs, and effectively decriminalizes personal drug importation,
but with a lot of gray! The changes were part of a major overhaul of the Drug Administrative Law
of the People’s Republic of China (DAL). The previous linked to page is in
Chinese but you can use Google translate to read it in English or another
language. A summary in English can be found here:
of Revised Chinese Drug Administration Law
For supporters of online access to safe and affordable
imported medicines, this is kind of cool.
(more…)Tagged with: China, Gleevec, lu yong