Articles Posted in Labeling

Thumbnail image for Thumbnail image for Thumbnail image for Thumbnail image for gavelgold.jpgZogenix, Inc., the San Diego-based manufacturer of the extended-release hydrocodone drug Zohydro ER, has sued the Governor of Massachusetts in U.S. District Court in Boston to overturn as unconstitutional the state’s recent prohibition against prescribing and dispensing the medication.

Zohydro ER is the only FDA-approved hydrocodone drug indicated for daily, round-the-clock, long-term treatment of chronic pain for which other pain treatments are inadequate. The product, which was approved last year, is also the only available extended-release opioid drug containing hydrocodone alone, not combined with acetaminophen, which has been associated with liver damage.

The Governor of Massachusetts recently issued an “emergency declaration” establishing the ban, without consulting Zogenix, on the ground that a hydrocodone-only drug presents a greater risk of overdose and abuse than a hydrocodone combination drug. The ban would remain in place until “adequate measures are in place to safeguard against the potential for diversion, overdose and misuse.”
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genericdrug.jpgFDA is proposing to amend its regulations to permit generic drug companies to add or strengthen safety warnings in labeling of their products on the basis of newly acquired safety information, even before the Agency has approved this safety information in the labeling of corresponding brand name drugs.

Under current rules, a generic drug must have the “same labeling” as its reference listed drug. This prevented an ANDA holder from inserting or altering a safety communication unless and until FDA has approved this information in the labeling of the brand name drug.

The purpose of the amendment is to “level the playing” field for generics, which arises from two conflicting Supreme Court decisions involving Federal preemption of safety warnings in prescription drug labeling. In Wyeth v. Levine, the Court held that a failure to warn claim in a Vermont personal injury action was not preempted by FDA labeling regulations, because the brand name drug company could have voluntarily amended its labeling to include a stronger safety warning even if FDA had not approved it. In contrast, the Court subsequently held in Pliva v. Mensing that a state failure to warn claim was preempted by FDA-approved labeling, since the generic company could not unilaterally add or strengthen its warning due to the same labeling requirement.
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On September 11-12, FLH’s Partner Brian J. Malkin will attend GPhA[Generic Pharmaceutical Association]/FDA’s ANDA [Abbreviated New Drug Application] Labeling Workshop / USP [United Pharmacopeial Convention] User Forum. The Conference provides a unique opportunity for attendees to hear straight from FDA’s Office of Generic Drugs (“OGD”) Labeling Review Staff, who are responsible for reviewing and approving ANDAs. The Workshop will provide industry with current information on the ANDA labeling review process as well as the many issues facing the generic industry when submitting ANDA labels. Some key topics to cover include:

  • Recommendations for industry on handling last-minute labeling “carve-outs”
  • The impact of REMS on the ANDA labeling review process
  • MedGuide Requirements>
  • Risk management plan challenges
  • Pediatric exclusivity considerations
  • Best practices for ANDA labeling

In addition, the Conference features presentations from USP staff about recent trends in USP’s monograph process and how changes in monographs can affect ANDA labeling and approvability. USP is a scientific, nonprofit organization that sets standards for the identity, strength, quality, and purity of medicines. Some of the topics USP staff will cover include pharmaceutical quality standards and the USP-NF standards- setting process, in addition to the following topics:

  • Pending Monograph process
  • Flexible Monographs
  • General Chapters Updates
  • Navigating the USP-NF
  • General Notices
  • USP Dictionary of USAN

In addition, USP will explain how members of the pharmaceutical community may get involved with the USP monograph process and more.

mortar and pestle.jpgThe U.S. Food and Drug Administration (“FDA”) announced last Tuesday that it would not approve any generic versions of the original formulation of the prescription narcotic painkiller OxyContin® (“original Oxycontin®”). OxyContin® is a brand name for oxycodone hydrochloride, an opiate-based pain medication. Original Oxycontin® has been marketed by Purdue Pharma since 1995 and is notorious for its user misuse and abuse.

OxyContin® contains a large amount of oxycodone because it is designed to release the pain-relieving drug over an extended 12-hour period. However, original Oxycontin® can easily be crushed and then snorted or injected (or even sprinkled on food) to produce a rapid and intense euphoric high. The abuse of original OxyContin® in this manner can lead to addiction and dependence and has reportedly earned the product the nickname “hillbilly heroin.” Its accessibility has magnified abuse rates; FDA reports that half a million people over age twelve began using original OxyContin® for non-medicinal purposes in 2008 alone. According to the Center for Disease Control, the death toll from prescription painkiller overdoses tripled in the first decade of the 21st century, and such overdoses “now kill more Americans than heroin and cocaine combined.”

In addition to a patent for original OxyContin, which expired on Tuesday, Purdue Pharma also owns a patent for a reformulated, abuse-deterring version (“reformulated Oxycontin®”). This newer version was designed to resist being crushed and to form a gel that is difficult to inject when dissolved. Notably, FDA approved an updated label for this product last week, specifying the tablets’ crush-resistant properties and warning of the fatal risks of misuse. (The label information is available here.) Purdue withdrew original OxyContin® from the market when its new version was approved in 2010 but retained the trade name.
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alabama.jpgOn January 16, 2013, FLH Partner Brian J. Malkin was quoted in FDAnews article: “Alabama Supreme Court: Brand Drugmakers Can Be Held Liable for Generic-Drug Labeling”. The Alabama Supreme Court recently held that Pfizer Inc. (“Pfizer”) could be sued for injury caused by a generic version of its drug. FDAnews asked Mr. Malkin how this could affect branded drug manufacturers makers and whether this decision would contradict federal laws and court rulings. Below is an excerpt from that story:

The Alabama court decision raises the question of whether states or the federal government should have had jurisdiction over the matter, Brian Malkin, a Partner at Frommer Lawrence & Haug told DID.

“If it is fraud, it is fraud on a national level so you would think the case should have gone to the FDA,” Malkin said. He has noticed a tension between state-specific and FDA authority in this arena and has noted a couple of cases where states seem to be taking on areas that are traditionally in the FDA’s realm. The Mutual v. Bartlett generic preemption case set to be heard by the Supreme Court this spring also began at the state court level, Malkin said (DID, Dec. 3, 2012).

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antiaging.jpgOn October 5, FDA sent a warning letter to Avon Products, Inc. (“Avon”) concerning the cosmetic company’s online promotion of its anti-aging skin care products. The letter, which FDA posted last week, objects to Avon’s marketing claims for a variety of its anti-wrinkle products. Specifically, it warns that they “appear to be intended for uses that cause these products to be drugs under section 201(g)(1)(C) of the Federal Food, Drug, and Cosmetic Act [‘FD&C Act’].”

The cited statutory provision (21 U.S.C. § 321(g)(1).) defines “drug” to include “articles (other than food) intended to affect the structure or any function of the body of man or other animals.” FDA asserts that Avon’s marketing claims indicate that the creams and serums listed in the letter are intended to affect the structure of human skin tissue, in which case they would fall under that definition. For example, the company’s website describes that the Anew Clinical Advanced Wrinkle Corrector as “formulated to boost shock-absorbing proteins to help strengthen skin’s support layers,” and “start rebuilding collagen in just 48 hours.” While it is not out of the ordinary for anti-wrinkle products to claim to reduce the appearance of wrinkles and fine lines, FDA believes that Avon’s statements go too far. According to the letter, the products are “not generally recognized among qualified experts as safe and effective for the above referenced uses” and are thus new drugs, requiring marketing approval.

Written by Rachael P. McClure

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Congress has prohibited the introduction of new drugs into interstate commerce without filing, and subsequent approval of, a new drug application (“NDA”) as stated in 21 U.S.C. § 355(a). A new drug application (“NDA”) must include, among other things, “full reports of investigations which have been made to show whether or not such drug is safe for use and whether such drug is effective in use.” Id. at § 355(b)(1). Other requirements address labeling information and manufacturing controls. Id. The warning letter asks Avon to review its website and product labels and requests a response within 15 days of receipt (October 20) detailing the steps the company has taken to correct the alleged violations. At least some of the accused descriptions still seem to remain on Avon’s website.
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On July 26, FLH Partner Brian J. Malkin was interviewed and quoted in FDAnews’ article: “Jazz Petitions FDA, Alleges Agency Wrongly Accepted Xyrem ANDA” available here (subscription required for full story). Malkin and another FDA attorney, David Rosen, were both quoted in the article to provide some color surrounding Jazz’s latest Citizen Petition regarding generic Xyrem® (sodium oxybate):

Despite Jazz’s arguments, David Rosen, an attorney at Foley & Lardner, questions whether the FDA actually accepted an incomplete application. The FDA, including the Office of Generic Drugs, is well aware of REMS requirements and wouldn’t accept an ANDA application if it was deficient on its face, Rosen told DID, noting there is more than one way to put appropriate controls in place for drugs. “The FDA has been taking [ANDA] filings seriously,” he said, adding he is confident the FDA is good at judging completed applications.

And Brian Malkin, an attorney at Frommer Lawrence & Haug, explained that because Jazz’s Xyrem REMS is still pending and not yet accepted by the agency, generic filers would typically only be required to include the “same essential elements” of a risk management plan in their ANDA application, a flexible approach that could have been satisfied by Roxane. ANDA filers for companies with approved REMS are held to a different standard, Malkin explained.

As FDA Lawyers Blog previously reported here, Jazz’s latest Citizen Petition focuses on FDA’s same labeling requirement for generic drugs and argues that risk management programs are included in that same labeling.

Jazz’s Xyrem Citizen Petition

While Xyrem® has been designated by FDA as a product that has been deemed to have a Risk Evaluation and Mitigation Strategy (“REMS”), FDA does not list Xyrem® as a product with an approved REMS. To some extent, Xyrem® ‘s risk management program called the Xyrem® Success Program has been described on its website and in FDA’s review package and public documents for Xyrem®.
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Earlier this month, Jazz Pharmaceuticals (“Jazz”) submitted a Citizen Petition requesting that the FDA rescind its acceptance of Roxane’s abbreviated new drug application (“ANDA”) referencing Xyrem®, an oral solution indicated for the treatment of patients with narcolepsy. In its petition, Jazz argues that Roxane’s ANDA did not have the same labeling and conditions of use as Xyrem®, because it did not contain a risk management system when it was submitted. Jazz asks that the FDA require Roxane to file a new ANDA, which would result in a new thirty-month stay of the associated New Jersey Hatch-Waxman litigation.

Jazz’s Xyrem Citizen Petition

Xyrem® is the sodium salt of gamma-hydoxybutyric acid (“GHB”), a notorious “date-rape” drug. In 2000, Congress passed the Hillory J. Farias and Samantha Reid Date-Rape Drug Prohibition Act, defining GHB as a Schedule I controlled substance but creating an exception for FDA-approved drugs containing GHB. FDA approved Xyrem® in 2002, requiring extraordinary restrictions on the drug product’s use under 21 C.F.R. § 314, Subpart H, including a restricted distribution program, an education program, restrictions on the distribution of prescriptions, and a registry system. To meet these demands, Jazz implemented and patented the “Xyrem® Success Program,” and listed the patents claiming methods of using its program in FDA’s Orange Book.

Jazz claims that Roxane’s ANDA did not include a proposed risk management system when it was submitted. Instead, Jazz explains that Roxane submitted a six-page document describing a partial proposed risk management program for generic Xyrem® ten months after its initial ANDA submission and did not submit a full proposal until more than a year after the initial ANDA submission.
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aidsart.pngOn Monday, July 16, FDA approved the first drug to be used for preventing Human Immunodeficiency Virus (“HIV”) infection, in what reporters are calling “a milestone in the 30-year battle against the virus that causes AIDS,” a “huge step toward controlling the spread of HIV,” and a contributing factor to “the turning point in the AIDS epidemic.” Truvada®, a pill owned by Gilead Sciences, is a drug used to treat HIV and Acquired Immunodeficiency Syndrome (“AIDS”) since 2004. However, Monday’s approval permits Gilead Sciences to market the drug for preventative use, potentially dramatically increasing the number of doctors prescribing the drug for that use. Using Truvada® as a preventative measure could help slow the spread of HIV, which currently infects about 50,000 new Americans per year.

Truvada® is a combination of two anti-HIV medications: Emtriva® (emtricitabine) and Viread® (tenofovir disoproxil fumarate). The two medications are combined into a single pill that is taken once a day with or without food. The drug works by lowering the amount of virus circulating in infected people’s blood. Truvada® blocks the activity of the enzyme (HIV-1 reverse transcriptase) the virus needs to replicate and consequently slows down the progression of HIV by limiting its ability to take hold and start an infection.

Written by Elizabeth Zinke

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The drug is approved for use by healthy, uninfected individuals who are at high risk of contracting HIV. Individuals considered “high-risk” include sex workers and people with HIV-positive partners. Additionally, people who engage in high-risk behaviors such as using intravenous drugs fall into the “high-risk” category. To prevent HIV infection, or at least reduce the risk of HIV infection, uninfected individuals at a high-risk of acquiring the virus must take the drug daily before and after exposure. Prevention, however, comes at a steep cost. A Truvada® prescription ranges from about $11,000 to $14,000 annually.
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Off-Label Communications:
The Definitive Legal and Regulatory Forum on the Evolving Off-Label Landscape Monday, June 25 to Tuesday, June 26, 2012 The Carlton on Madison, New York, NY
Attendees of ACI’s Off Label Communications Conference will:

  • Benchmark best practices against leading companies such as Endo Pharmaceuticals, Lundbeck Pharmaceuticals, Novo Nordisk, Pfi zer, Purdue Pharmaceuticals, Sandoz and many more
  • Learn how to reposition your company’s policies and protocols according to these shifting boundaries and determine what’s fair and foul in off-label communications and promotion
  • Master preparation skills for the new off-label framework based on the free speech defense
  • Hear directly from the FDA and DOJ and several former federal prosecutors on how to guard proactively against impermissible off-label communications
  • Over the years, previous attendees have demanded even more in-depth information on responding to government investigations so this year we are pleased to offer a customized post-conference Master Class on Creating a Culture of Compliance: Best Practices for Working with the FDA and DOJ in an Off-Label Investigation.

FDA Lawyer’s blog readers are entitled to a discount when referencing the code: FDA 200
For more information on how to register, please visit our website: