Source: http://www.fdalawblog.net/fda_law_blog_hyman_phelps/importexport/
Timestamp: 2016-05-04 19:12:46
Document Index: 261298626

Matched Legal Cases: ['§ 890', '§ 381', '§ 1', '§ 1', '§ 271', '§ 271', '§ 1001', '§ 314', '§ 271', '§ 271', '§ 1001', '§ 8', '§ 706', '§ 527', '§ 503', '§ 505', '§ 701', '§ 801', '§ 201', '§ 8']

FDA Law Blog: Import/Export FDA Law Blog
By Kurt R. Karst – In a 19-page decision handed down earlier this week by Judge Nancy Torresen of the U.S. District Court for the District of Maine, the court ruled that Maine’s 2013 law, titled “An Act To Facilitate the Personal Importation of Prescription Drugs from International Mail Order Prescription Pharmacies,” 2013 Me. Legis. Serv. Ch. 373 (S.P. 60) (L.D. 171) (West) (the “Maine Pharmacy Act Amendments” or “MPA Amendments”) permitting (as its title suggests) importation of drug products into the U.S. from licensed retail pharmacies located in certain foreign countries (i.e., Canada, Australia, New Zealand, and the United Kingdom), is unconstitutional under the theory of field preemption. In doing so, Judge Torresen granted a Motion for Judgment on the Pleadings filed by two Maine pharmacists and three Maine trade associations (the Maine Pharmacy Association, Maine Society of Health-System Pharmacists, and Retail Association of Maine), and denied a Motion for Judgment on the Pleadings filed by Maine’s Attorney General (Janet T. Mills) and Commissioner of Administrative & Financial Services (formerly H. Sawin Millett, Jr., and now Richard Rosen). The February 23rd decision stems from a September 2013 Complaint filed by the Plaintiffs, as well as then-Plaintiff the Pharmaceutical Research and Manufacturers of America (“PhRMA”), challenging the MPA under several theories (see our previous posts here and here). PhRMA was tossed out of the lawsuit last May after the district court ruled that the trade organization lacked Article III standing (see our previous post here). The State Defendants argue that the MPA Amendments “simply reduce the reach of the MPA,” “that it is within [the State’s] authority as a sovereign to choose not to regulate certain conduct,” and that to hold otherwise “would violate the Tenth Amendment principle that states may not be compelled to administer federal regulatory programs.” On the other side, the Maine pharmacist and trade association Plaintiffs argue that the FDC Act “creates a comprehensive and ‘closed’ regulatory scheme, which strictly limits the introduction of prescription drugs into interstate commerce,” and that preempts the MPA Amendments under three theories of preemption: (1) field preemption (i.e., when “[t]he intent to displace state law altogether can be inferred from a framework of regulation ‘so pervasive . . . that Congress left no room for the States to supplement it’ or where there is a ‘federal interest . . . so dominant that the federal system will be assumed to preclude enforcement of state laws on the same subject.’” Arizona v. United States, 132 S. Ct. 2492, 2501 (2012) (quoting Rice v. Santa Fe Elevator Corp., 331 U.S. 218, 230 (1947)); (2) direct conflict preemption (i.e., a form of implied preemption that occurs when there is an inescapable contradiction between state and federal law); and (3) obstacle preemption (i.e., when “the challenged state law ‘stands as an obstacle to the accomplishment and execution of the full purposes and objectives of Congress.’” Arizona, 132 S. Ct. at 2501 (quoting Hines v. Davidowitz, 312 U.S. 52, 67 (1941)).
It is unclear at this time whether or not an appeal will be made to the U.S. Court of Appeals for the First Circuit. According to press reports (here), the sponsor of the bill that was enacted as the MPS Amendments, State Senator Troy Jackson, thinks an appeal is in order. Moving down the Eastern Seaboard to Capitol Hill, earlier this year Senators John McCain (R-AZ) and Amy Klobuchar (D-MN) introduced S. 122, the Safe and Affordable Drugs from Canada Act of 2015, which would amend the FDC Act to require the Department of Health and Human Services to promulgate regulations within 180 days permitting individuals to import a prescription drug purchased from an approved Canadian pharmacy under certain specified conditions.
Posted at 07:40 PM in Import/Export, Prescription Drugs and Biologics | Permalink
On November 3, 2014, the law firm of McKenna Long & Aldridge LLP filed suit on behalf of Plymouth Direct, Inc. (Plymouth) and Natures Pillows, Inc. (NPI) in the United States District Court for the District of Columbia against FDA claiming that FDA unlawfully detained multiple shipments of the companies’ medical device, the BeActive® Brace, that were imported into the U.S. According to the companies’ Complaint, BeActive is manufactured in China and sold by Plymouth and NPI in the United States through retail and mail order channels. BeActive is a wrap brace that puts pressure on the wearer’s calf muscle, thereby reducing tension on the sciatic nerve, which can reduce lower back pain. In April 2014, Plymouth and NPI’s supplier (Base4 Group Inc.) sent an email to FDA with BeActive’s packaging and labeling and sought FDA’s opinion as to the product’s classification (see court document here). Based on the information provided in the court filings, the draft labeling explained that the brace was used to apply pressure to the calf muscle to relieve back pain – the device’s fundamental principle of operation. FDA responded stating that BeActive was a Class I, 510(k)-exempt, Limb Orthosis, pursuant to 21 C.F.R. § 890.3475. Plymouth and NPI began selling BeActive in August 2014. The Complaint states that between September 27, 2014 and October 20, 2014, FDA subjected seven shipments of the product to Detention without Physical Examination because BeActive lacked 510(k) clearance. Specifically, FDA indicated that BeActive’s claim that it can relieve back pain caused by pregnancy and piriformis syndrome requires 510(k) clearance. In addition, FDA indicated that BeActive could be an acupressure device because of how the product achieves its intended effect, and acupressure devices could be subject to 510(k) premarket notification requirements (see court document here). FDA subsequently released all seven shipments on the grounds that although the product appeared violative, the violation was a minor violation. According to the Complaint, two more BeActive shipments were detained on October 28, 2014 – six days before the Complaint was filed. As part of the detention, FDA indicated that it was in the process of adding BeActive to an Import Alert for failure to have a 510(k) clearance. In an effort to resolve the import detentions, the Complaint states that Plymouth and NPI proposed changing BeActive’s packaging, labeling, and promotional materials to remove the “objectionable” claims. In addition, the companies offered to file a 510(k) for BeActive, provided that they could continue selling while the 510(k) was pending. The Complaint reports that these proffers were made between October 24 and 28, 2014, and as of the date of the Complaint, FDA had not responded. The Federal Food, Drug, and Cosmetic Act (the FD&C Act) establishes procedures for the FDA and U.S. Bureau of Customs and Border Protection (CBP) to work together to admit or deny import of medical devices into the U.S. Through this process, set out in the statute and regulations, FDA or CBP can take samples of devices to determine if they are adulterated or misbranded. 21 U.S.C. § 381(a). If samples are taken, the medical devices must be held until they are cleared for sale into interstate commerce. 21 C.F.R. § 1.90. These procedures also allow for an informal hearing if import is denied. 21 C.F.R. § 1.94. In addition, as an alternative to the process in the statute and regulations, FDA has created the “Detention without Physical Examination” process in its Regulatory Procedures Manual. Through the Detention without Physical Examination process, FDA does not actually take samples of the devices. Rather, FDA requires the recipient of the devices to hold the devices while the importer provides documentation demonstrating that the devices do not meet the criteria for import refusal. The Detention without Physical Examination process is the method employed by FDA in this case, and it is also the method most commonly used to detain imports of medical devices subject to enforcement action (e.g., a Warning Letter that includes an import alert). FDA believes this process is less burdensome on FDA’s resources than having to take physical samples of products that are delivered into the U.S., when FDA has already determined that the product is adulterated or misbranded. Thus, if a court found this process to be unlawful, it could significantly change the way that FDA and CBP handle import detentions of medical devices.
Given the very short timeframe in which these facts have transpired, we wonder if FDA considered Plymouth and NPI’s offer to modify BeActive’s packaging, labeling and promotional claims before the companies filed this lawsuit. This offer was likely made about a week and a half before the companies filed this suit. However, it appears to have worked in Plymouth and NPI’s favor. While the information regarding the two most recent shipments of BeActive in FDA’s import system has not been updated, this case was voluntarily dismissed by the companies on November 6, 2014. We can assume that, based on the voluntary dismissal, that FDA and the companies likely came to an agreement to release the detained product and a pathway forward for future shipments.
Although we will not have any legal resolution as to the interesting questions raised by this case, it is a recent example of a lesson that can often be forgotten in a regulatory framework where companies usually want to work with the Agency to resolve disputes – sometimes litigation is the answer. Particularly when it comes to import alerts and detentions that companies have trouble (or cannot) resolve with FDA, history shows us that litigation can be a very effective tool. A recent review by HPM of cases in which companies challenged an FDA import alert or detention in court showed that the company typically prevailed. In fact, in most of these cases, soon after the case was filed, it was dismissed, usually, if not always, because the import alert or detention was vacated by FDA. Posted at 03:10 PM in Import/Export | Permalink
Relieving the Tension Between FDA’s PLAIR Program and Hatch-Waxman: A New Paper Suggests A Remedy By Kurt R. Karst – FDA’s Pre-Launch Activities Importation Request (“PLAIR”) program got a lot of attention last July when the Agency finally announced the issuance of a draft guidance document (Docket No. FDA-2013-D-0836) describing the program. Briefly, the PLAIR program allows, on a case-by-case basis and subject to FDA’s discretion, the importation and warehousing of finished drug and biological products where an application for approval (i.e., an NDA, ANDA, or BLA) is pending and where the import and warehousing will expedite the commercial launch of the product once FDA approves a marketing application.
We started talking about FDA’s PLAIR program years before the Agency issued formal guidance (see our previous post here). In a later post (May 2012), we discussed a case – Sanofi-Synthelabo v. Apotex, Inc. – clearly showing some tension between FDA’s PLAIR program and Hatch-Waxman. We won’t get into the specifics of the case here, as readers can refer to our previous post for the details. However, in a nutshell, ANDA sponsor Apotex (the only company to have thus far commented on FDA’s draft PLAIR guidance) was, pursuant to an Order issued under 35 U.S.C. § 271(e)(4), permanently enjoined from “engaging in the commercial manufacture, use, offer to sell or sale within the United States, or importation into the United States” of its generic version of PLAVIX (clopidogrel bisulfate) Tablets until the expiration of a particular patent (and any associated pediatric exclusivity). As Apotex was gearing up for ANDA approval, the company asked for an amended Order permitting importation of its drug product into the U.S. as a result of a PLAIR request submitted to FDA. The request for an amended Order was denied by both a district court and the Federal Circuit. A new article published in the Hastings Science & Technology Law Journal authored by Alex Cheng and Matthew Avery, titled “The Conflict Between the FDA's Pre-Launch Activities Importation Request Program and the Hatch-Waxman Act,” further explores FDA’s PLAIR program. It takes a close look at the tension between PLAIRs and the Hatch-Waxman Amendments, and, in particular, in the context of the Sanofi case.
Noting that “[i]f a district court issues a permanent injunction pursuant to section 271(e)(4) of the Patent Act to prohibit the generic company from importing its infringing drug product before the date that the patent expires, then the generic should not be able to take advantage of PLAIR to import its generic drug into the United States ahead of anticipated ANDA approval,” the authors suggest both an amendment to FDA’s PLAIR guidance and to 35 U.S.C. § 271(e)(4). First, write the authors:
To ensure that the FDA does not approve PLAIR requests during the term of a patent injunction, the FDA should amend the PLAIR process so that an applicant is required to submit information identifying any injunctions that may prohibit importation of its product. For example, the FDA could amend the PLAIR Draft Guidance to require the following be included with all PLAIR requests:
(j) A letter signed by an authorized representative of the applicant certifying under 18 U.S.C. § 1001 that the applicant is not a party to a court order subject to an injunction prohibiting importation of the drug product.
This requirement will save both the FDA and the courts resources. Such a requirement would allow the FDA to reject PLAIR requests that seek to illegally import products during the term of an injunction (or to summarily deny such requests if they fail to submit this required information). In turn, this would prevent courts from having to weigh in on whether importation under the PLAIR request is proper.
Although ANDA (and 505(b)(2)) applicants are currently required to notify FDA of court actions (see 21 C.F.R. § 314.107(e)), it seems unlikely that the FDA components to which these notifications are sent (i.e., the Office of Generic Drugs or a particular Division in the Office of New Drugs) would, as a matter of course, apprise the Agency’s PLAIR team in the event a PLAIR has been (or will be requested). As such, this proposed additional element to a PLAIR request seems to make sense.
Second, the authors suggest a revision to 35 U.S.C. § 271(e)(4), as reflected in the bolded and italicized typeface below: For an act of infringement [caused by filing an ANDA with a Paragraph IV certification] – (A) the court shall order the effective date of any approval of the drug . . . to be a date which is not earlier than the date of the expiration of the patent which has been infringed, (B) injunctive relief may be granted against an infringer to prevent the commercial manufacture, use, offer to sell, or sale within the United States or importation into the United States of an approved drug, veterinary biological product, or biological product, except importation into the United States shall be allowable to the extent that such importation is permitted by the Food and Drug Administration pursuant to a Pre-launch Activities Importation Request, . . . .
This amendment, say the authors, “would allow generic companies to import their products during the term of an injunction, while still prohibiting them from actually marketing their products until the brand-name manufacturer’s patent expires, thereby protecting the pioneer’s patent rights.” In addition, the authors state that 35 U.S.C. § 271(e)(4) could be “further amended to only allow importation if the PLAIR applicant submits a letter signed by an authorized representative certifying under 18 U.S.C. § 1001 that it will not sell, offer to sell, or distribute its product prior to receiving final marketing approval from the FDA.” Such amendments to the statute would appear to be a sufficient way to both protect patent rights and place all ANDA sponsors (both domestic and foreign) in a similar marketing position. Posted at 11:22 PM in Hatch-Waxman, Import/Export, Prescription Drugs and Biologics | Permalink
By Kurt R. Karst – Earlier this week, the U.S. District Court for the District of Maine came one step closer to a merits ruling in a lawsuit filed last September by two Maine pharmacists, three Maine trade associations (the Maine Pharmacy Association, Maine Society of Health-System Pharmacists, and Retail Association of Maine), and the Pharmaceutical Research and Manufacturers of America (“PhRMA”) against Maine’s Attorney General (Janet T. Mills) and Commissioner of Administrative & Financial Services (H. Sawin Millett, Jr.) in an effort to stop implementation of a state law permitting the importation of drug products into the U.S. from licensed retail pharmacies located in certain foreign countries. That state law, titled “An Act To Facilitate the Personal Importation of Prescription Drugs from International Mail Order Prescription Pharmacies,” 2013 Me. Legis. Serv. Ch. 373 (S.P. 60) (L.D. 171) (West) (the “2013 Act”), went into effect on October 9, 2013, and has been challenged as preempted by the FDC Act pursuant to the U.S. Constitution’s Supremacy Clause (U.S. Const. art. VI, cl. 2) and by the Foreign Commerce Clause of the U.S. Consittution (U.S. Const. art. I, § 8 cl. 3). We’ve previously reported on the case here and here, so you can refer to those posts for additional background information. The challenge to the 2013 Act is the topic of a fully briefed Motion for Preliminary Injunction (here, here, and here) and a fully briefed Motion to Dismiss for lack of standing and for failure to state a claim for which relief may be granted (here, here, and here). Both motions came under advisement late last October. Several weeks later, the Plaintiffs filed a notice of intent to file a Motion for Summary Judgment saying that the case can be resolved purely as a matter of law on Cross-Motions for Summary Judgment on the issue of whether the 2013 Act is preempted by federal law. Summary Judgment motions have not yet been filed – and there’s been some dispute about that process, leading up to a recent Motion for Expedition and request to initiate summary judgment briefing – but before even going there, the Court must first dispense with the Defendants’ Motion to Dismiss (and Motion for Preliminary Injunction, unless it is withdrawn). Earlier this week, Judge Nancy Torresen issued a 17-page Order dispensing with Defendants’ Motion to Dismiss. The outcome: trimmed down lists of Plaintiffs and claims. In its Motion to Dismiss, the State contends that the Plaintiffs lack both constitutional and prudential standing to challenge the 2013 Amendment (and also argues that all claims against Commissioner Millett should be dismissed). According to the State:
Posted at 08:18 PM in Import/Export, Prescription Drugs and Biologics | Permalink
FDA Sued Over Failure to Issue Export Certificate
We have long been waiting for a company to sue FDA for failing to issue an export certificate. Unfortunately, we may need to wait a bit longer for a case that will resolve the standards for when FDA must issue an export certificate. Today, one can argue that FDA is “allowing” companies to sell products in the U.S. when FDA is unreasonably prohibiting the same products from being shipped outside the U.S.
As background, export certificates, while not mandated by the Federal Food, Drug, and Cosmetic Act (“FDC Act”), have become a practical requirement for many companies seeking to market their U.S.-manufactured products globally. Foreign customers and importing countries generally require that these FDA-issued certificates accompany the import of a regulated product, and some countries rely on certain types of export certificates before issuing their own product approvals/registrations. Under the FDC Act Section 801(e)(4), exporters may request, and if criteria are met FDA is required, to issue an export certificate within 20 days of a request. There are several types of export certificates (see here and here) that exporters may request – those that certify a product may be legally marketed in the U.S. as well as those that simply certify a product may be legally exported from the U.S. A typical reason FDA may refuse to issue the first type of export certificate for a drug or device is FDA’s concern over whether the company is manufacturing the product in conformance with current good manufacturing practices (“cGMPs”) or FDA’s quality system regulations (“QSRs”). In fact, FDA often refuses to issue these certificates if the company has received a Warning Letter relating to those regulations. We are aware that in such circumstances, FDA has refused to issue an export certificate until the Warning Letter “close-out” process has been completed. As we have previously blogged, this close-out process can take many months and it is unclear whether the delay is due to industry failure to correct serious regulatory problems or whether FDA is unwilling to conduct prompt follow-up to confirm corrections. FDA’s failure to timely issue a Warning Letter “close-out” in many instances may lead to its failure to issue an export certificate – even where the company may already be in substantial compliance. When FDA fails to issue an export certificate, it can effectively destroy a company’s ability to market its U.S. manufactured product outside the U.S. although there may be no impact on the company’s sales in the U.S. market, because FDA has not taken enforcement action to block the domestic sales of relevant product.
We were eager to read Pharmaceutical Innovations, Inc. (“PI”)’s complaint seeking declaratory judgment and injunctive relief to compel the FDA to issue a Certificate to Foreign Government (“CFG”), a type of export certificate that certifies a product may be legally marketed in the U.S. PI manufactures and markets ultrasound gel, which is regulated by FDA as a medical device. As we read the complaint, and reviewed FDA’s website, we were curious as to PI’s assertion that FDA has not taken any action to restrain PI from distributing its devices in interstate commerce. FDA’s website shows that, in addition to a Warning Letter relating to QSR violations, certain lots of PI’s products are the subject of an open Class I recall, and that Deputy U.S. Marshals, at FDA’s request, had seized certain lots of PI’s product in April 2012. This action was undertaken less than one month before FDA’s denial of PI’s request for a CFG in May 2012. In addition, the July 2011 Warning Letter to PI advises, “Requests for Certificates to Foreign Governments will not be granted until the violations related to the subject devices have been corrected.” According to FDA’s website, the PI Warning Letter has not, to date, been subject to “close-out.”
PI maintains that it is currently manufacturing and distributing its products in the U.S. with no action from FDA to restrain the manufacture or distribution of these products. PI also maintains that it has “responded fully and completely to the warning letter as well as to subsequent FDA inspectional observations and has repeatedly expressed its desire to meet with FDA officials to address the issues raised therein.” PI further alleges that FDA has not responded to numerous written communications and verbal requests to FDA representatives for a meeting. It is unclear whether FDA still has concerns about the quality of PI’s product, or whether FDA resources are hampering its ability to issue a Warning Letter “close out.” If the issue is the latter, FDA’s inability to timely issue a Warning Letter “close out” is unreasonably (and unfairly) harming the company’s ability to obtain a CFG. If the former, one could argue that FDA’s failure to take further action against products in domestic commerce could be viewed as FDA “allowing” the company to distribute products that FDA would otherwise view as adulterated or misbranded.
We are anxious to see whether PI will be successful in its suit. If not, we will wait to see whether, if the facts were different, a lawsuit filed by another company without a Warning Letter “close-out” could be successful in requiring FDA to issue an export certificate.
Posted at 08:24 PM in Import/Export | Permalink
By Kurt R. Karst – With primary briefing over (briefs here, here, and here), and a December 13, 2013 Oral Argument before Judges Griffith, Kavanaugh and Randolph concluded, we were waiting with bated breath for the U.S. Court of Appeals for the District of Columbia Circuit to rule on K-V Pharmaceutical Company’s (“KV’s”) appeal of a September 2012 decision from the U.S. District Court for the District of Columbia that stymied the company’s efforts to “restore” orphan drug exclusivity for the pre-term birth drug MAKENA (hydroxyprogesterone caproate) Injection, 250 mg/mL, the compounded version of which is known as “17P.” In an interesting turn of events, the DC Circuit issued an unpublished judgment on January 7, 2014 ordering and adjudging that the DC District Court’s September 6, 2012 order dismissing KV’s claims be vacated and that the case be remanded to the district court for reconsideration in light of the DC Circuit’s July 23, 2013 decision in Cook v. FDA, 733 F.3d 1 (D.C. Cir. 2013), and the November 27, 2013 enactment of the Drug Quality and Security Act (“DQSA”), Pub. L. No. 113-54, 127 Stat. 587 (2013). In Cook, the DC Circuit largely affirmed a March 2012 decision from the DC District Court permanently enjoining FDA from permitting the entry of (or releasing any future shipments of) foreign manufactured thiopental into interstate commerce (see our previous post here). Title I of the DQSA, the Compounding Quality Act, concerns state and federal oversight of compounding of human drugs (see our previous posts here and here summarizing the DQSA). As we previously reported (here, here, and here), KV filed a Complaint and a Motion for Temporary Restraining Order and Preliminary Injunction alleging that FDA and the Department of Health and Human Services violated myriad provisions of the FDC Act, the Administrative Procedure Act (“APA”) § 706(2), and the Due Process Clause of the Fifth Amendment to the U.S. Constitution by failing to take sufficient enforcement action to stop the unlawful competition with MAKENA by pharmacies that compound 17P. FDA filed a Motion to Dismiss arguing, among other things, that KV’s claims are not justiciable for lack of standing, and that even if KV can establish standing, certain Agency statements concerning compounded 17P are not subject to judicial review under the APA because FDA’s decisions not to take enforcement action are committed to the agency’s discretion under Heckler v. Chaney, 470 U.S. 821 (1985). In Chaney, the U.S. Supreme Court held that “an agency’s decision not to prosecute or enforce, whether through civil or criminal process, is a decision generally committed to an agency’s absolute discretion,” and as such, is presumed to be unreviewable under the APA. After finding that KV alleged sufficient facts to support standing, the D.C. District Court found KV’s first three Counts concerning orphan drugs (FDC Act § 527(a)), compounding (FDC Act § 503), and new drug approval (FDC Act §§ 505(a) and 301(d)) unreviewable, because APA § 701 “precludes judicial review of final agency action, including refusals to act, when review is precluded by statute or ‘committed to agency discretion by law,” and because Chaney is controlling. Addressing Count IV of KV’s Compliant alleging that FDA violated FDC Act § 801(a) by permitting foreign-manufactured active pharmaceutical ingredient to be imported into the United States for compounding into 17P, the court found that the Count failed to state a claim.
The DC Circuit’s decision to vacate the DC District Court’s decision and remand the case to the district court for reconsideration follows a string of letters submitted to the Court over the past several months after the completion of briefing, but before the December 13th Oral Argument, concerning Cook and the DQSA. In those letters (available here, here, here, here, and here) KV and FDA dispute the relevance of the Cook decision and the DQSA’s provisions to the case at hand. So back to the DC District Court we go . . . and perhaps someday appealed again up to the DC Circuit.
Posted at 03:58 PM in Enforcement, Import/Export, Orphan Drugs, Prescription Drugs and Biologics | Permalink
Recently, a bill was introduced into the House of Representatives that would legalize personal importations and re-importations of certain foreign drugs. The Personal Drug Importation Fairness Act of 2013 (H.R. 3715) would allow Americans to buy prescription drugs from certain countries deemed to have comparable safety standards to the United States, including Australia, Canada, Israel, Japan, New Zealand, Switzerland, South Africa, and countries in the European Union. The drug imported must have the same active ingredients, route of administration, and strength as an FDA-approved prescription drug, and the purchase must be accompanied by a valid prescription for a supply not exceeding 90 days to be dispensed by a licensed pharmacist. The stated intent of the bill is to permit individuals access to drugs at lower costs. Although FDA prohibits the import of unapproved drugs, FDA’s current policy is to exercise enforcement discretion to allow certain personal imports that meet set criteria. FDA has repeatedly reminded consumers and industry that such imports are illegal and FDA’s exercise of enforcement discretion has been inconistent. Read more about FDA’s policy on these imports here, here, and here. The bill comes on the heels of Maine’s recent law that effectively legalized the import of certain prescription drugs from certain pharmacies. In mid-October 2013, Maine became the first state to permit its residents to legally import foreign drugs from accredited pharmcies in Canada, the U.K. and certain other countries (see our previous posts here and here). This bill may be an attempt by the federal government to curtail similar statutes from other states and to establish standards for the types of permissible imports.
Posted at 06:45 PM in Import/Export | Permalink
We recently became aware of a lawsuit filed against FDA in the Eastern District of New York over the importation of bulk drug product. In this suit, which also names an individual FDA Compliance Officer, the importer argues that FDA’s actions in refusing a shipment of bulk acetaminophen are overreaching, arbitrary and capricious, unlawful and discriminatory. The importer is requesting a temporary restraining order that would stay U.S. Customs and Border Patrol’s request for redelivery of the refused shipment, and a declaratory judgment that the acetaminophen that is the subject of the import is exempt from misbranding provisions of section 502(f)(1) of the Federal Food, Drug, and Cosmetic Act.
FDA apparently refused the shipment because of some unidentified policy against importing lawful product for future use or inventory, as well as a failure to document every customer that would be purchasing the finished goods (from the importer’s customer, not the importer). According to the Complaint, the importer, was seeking to import bulk acetaminophen to distribute to its contract manufacturer customer. The contract manufacturer provided an end-use letter that stated the acetaminophen would be further manufactured into over-the-counter drug products, and identified one of the brands that would be manufactured from the bulk product. The bulk acetaminophen, as proposed for import, had been labeled with the statement, “Caution: For manufacturing, processing, or repacking” in accordance with 21 C.F.R. § 201.122. In addition, the ultimate customer of the contract manufacturer also contacted the FDA prior to the refusal.
After over a month of correspondence, FDA refused the shipment through a formal FDA Notice of Refusal that stated, “DOCUMENTATION NEEDED TO REMOVE THE APPEARANCE OF VIOLATION, SUCH AS, APPROVED USE DOCUMENTATION. NO APPLICATION, USE OR END-USER TRANSMITTED. REQUIRED END-USE DOCUMENTATION NOT RECEIVED TO DATE.” Separately, by email, the Compliance Officer stated that it appeared the active pharmaceutical ingredient would be for future or stock/inventory use and “[c]urrent guidance for bulk APIs does not permit importation for stock/inventory use.” OTC drug products are often manufactured by a single manufacturer for many private label distributors. As long as the finished product is ultimately compliant, FDA’s refusal to permit the import of otherwise lawful bulk drug product simply because a customer for the finished product had not yet been identified at the time of import is difficult to understand, and does not appear to be consistent with the agency’s regulations on drugs intended to be further manufactured. It would be interesting to see whether an end-use statement that simply stated that the product would be manufactured and labeled in accordance with the pending OTC monograph would have sufficed in securing the release of this shipment.
Posted at 07:03 PM in Enforcement, Import/Export | Permalink
By Kurt R. Karst – We were reminded earlier today that a new law has gone into effect in the state of Maine permiting the importation of drug products into the state from licensed retail pharmacies located in certain foreign countries. As we previously reported, in September, the Pharmaceutical Research and Manufacturers of America (“PhRMA”), along with several other trade groups – the Maine Pharmacy Association, Maine Society of Health-System Pharmacists, and Retail Association of Maine – and two pharmacists, filed a Complaint and Motion for Preliminary Injunction against Maine’s Attorney General and Commissioner of Administrative & Financial Services in the U.S. District Court for the District of Maine in an effort to block implementation of the importation law. Plaintiffs allege in their filings that the Maine importation law is preempted under the Supremacy Clause of the U.S. Constitution (U.S. Const. Art. VI, cl. 2) because federal statutes, like the FDC Act and the 2003 Medicare Modernization Act (“MMA”), “occupy the field and the Maine law conflicts with and obstructs compliance with those statutes.” Plaintiffs also allege that the Maine law violates the Foreign Commerce Clause (U.S. Const. Art I, § 8 cl. 3) because it “purports to regulate in an area where the federal government possesses exclusive and plenary power.” That is, the state law violates the requirement that the federal government “speak[] with one voice in the area of international pharmaceutical trade” and discriminates against foreign commerce.
Moving on to the Foreign Commerce Clause, Defendants say that Plaintiffs’ theories are meritless. “The foreign Commerce Clause is concerned with state laws that discriminate against foreign commerce or that excessively interfere with foreign affairs. . . . [P]laintiffs filed this lawsuit because they are upset that the 2013 Amendment allegedly ‘authorizes’ foreign commerce at the expense of in-state commerce. Even assuming that were true, however, the 2013 Amendment does not violate the foreign Commerce Clause” (citation omitted). But these arguments all assume that Plaintiffs have standing to bring the lawsuit in the first place. They don’t, says Maine: This suit should be dismissed because no plaintiff has standing to assert violations of these constitutional provisions. The 2013 Amendment, which restricts the reach of the Maine Pharmacy Act, does not directly affect plaintiffs. No plaintiff is a retail pharmacy located outside the United States, and no plaintiff alleges that it plans to provide or facilitate the export of prescription drugs into Maine from a pharmacy located outside the United States. In short, no plaintiff alleges that it has engaged or plans to engage in conduct covered by the 2013 Amendment. Plaintiffs seek to enjoin the enforcement of an amendment that does not apply to them.
Plaintiff’s have requested that Oral Argument on the various motions in the case be scheduled for the week of November 4, 2013. The court has not yet set a hearing date. Posted at 06:41 PM in Import/Export, Prescription Drugs and Biologics | Permalink