Life Science Compliance Update

May 21, 2015

FDA OPDP Issues Fifth Letter of Caution for the Year, Cites Oak Pharmaceuticals For Exhibit Banner

Akorn

Almost like clockwork, the Food and Drug Administration’s Office of Prescription Drug Promotion (OPDP) has released its fifth enforcement letter of 2015—they have issued one letter in January, February, March, April, and now, as of the past week, one in May. OPDP sent the Untitled Letter to Oak Pharmaceuticals, Inc. (a subsidiary of Akorn, Inc.) regarding the company’s barbiturate anticonvulsant, Nembutal. View the promotional material here. The agency found that Oak’s table exhibit banner was misleading because it omitted “important risk information associated with the use of Nembutal,” and also omitted material facts. These violations caused the exhibit banner to be “misbranded” under the Food, Drug, and Cosmetic Act, noted OPDP.

Indeed, the banner is quite sparse, showing a picture of an approaching lightning storm, and stating: “Control the Uncontrollable. The control you need when seizures are at their worst,” followed by the product and company name. In small letters at the bottom, the banner notes: “See booth representative for full prescribing information and important safety information.” OPDP stated that this alert did not mitigate the fact that the banner leaves off risk information on the visual material itself.

In sending the Untitled Letter, OPDP reaffirms that all promotional material--including posters at exhibit booths—are subject to the requirement to be accurate and to balance all benefit information with risk information.

Background

The OPDP is the drug advertisement watchdog; the agency keeps a look out for false and misleading advertising and promotion through comprehensive surveillance. They inspect Form FDA-2253,  receive complaints from competitors, monitor promotional material at medical conferences, and have instituted the “Bad Ad” Program, which encourages doctors to alert the OPDP of potentially false or misleading advertisements. The Agency may then issue “Warning Letters” or less serious “Untitled Letters” to the manufacturers behind any problematic ads. Whereas Untitled Letters require companies to cease using the violative materials and recall them, Warning Letters may also require the company to make a plan for “corrective advertising,” which includes prompt dissemination of accurate and complete information.

Oak Untitled Letter

Oak Pharmaceuticals is a subsidiary of Akorn, Inc., and markets the Nembutal Sodium Solutions, a short-acting injectable barbiturate used to control seizures and for sedation. According to the OPDP, the company displayed an exhibit banner for Nembutal at the American Society of Health-System Pharmacists (ASHP) Meeting held in Anaheim, CA in December last year, which was viewed by two OPDP representatives. Oak received an Untitled Letter a few months later based on the banner’s omission of risks and omission of material facts. 

  • Omission of Risk Information

The Nembutal exhibit banner includes claims such as, “Control the Uncontrollable” and “the control you need when seizures are their worst;” however, it omits all of the contraindications, warnings and precautions, and common adverse reactions associated with the use of Nembutal, states OPDP. "By failing to present any risk information associated with Nembutal, the exhibit banner misleadingly suggests that Nembutal is safer than has been demonstrated."

FDA acknowledges that the statement: “SEE BOOTH REPRESENTATIVE FOR FULL PRESCRIBING INFORMATION AND IMPORTANT SAFETY INFORMATION,” is included at the bottom of the exhibit banner, but that it does not mitigate the misleading omission of risk information. Risks associated with barbiturates include, perhaps most notably, that they are habit forming. The product labeling for Nembutal also contains warnings and precautions regarding IV administration, acute or chronic pain, use in pregnancy, synergistic effects, and central nervous system (CNS) depressant effects. 

  • Omission of Material Facts

In addition to risks, OPDP found that the banner did not accurately portray the approved indication for the drug.  Specifically, the agency found the  materials omitted the fact that Nembutal should only be used "in anesthetic doses, in the emergency control of certain acute, convulsive episodes, e.g., those associated with status epilepticus, cholera, eclampsia, meningitis, tetanus, and toxic reactions to strychnine or local anesthetics."

OPDP's letter indicates that they request Oak to "immediately cease branding Nembutal," and to submit a written response to the agency's letter stating whether the company intends to comply with the request, listing all promotional materials (with the 2253 submission date) for Nembutal that contain presentations such as those described above, and explaining their plan for discontinuing use of such materials.

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Before sending this letter to Oak, OPDP most recently sent an Untitled Letter to Otsuka Pharmaceuticals in April, citing a pharmacology aid for their antidepressant and bipolar treatment, Abilify. This is a notable letter if solely because it implicates a large pharmaceutical company, and a bestselling drug that only recently received generic competition. OPDP criticized the ad, which showed three light switches at low, middle, and high to represent how Abilify can modulate dopamine and serotonin activity. However, “the totality of these claims and presentations misleadingly implies a greater degree of certainty about the mechanism of action of Abilify in humans than is currently known,” notes the letter. Furthermore, according to OPDP, the promo is “misleading because it implies that Abilify offers advantages over other currently approved treatments for bipolar disorder or [major depressive disorder] when this has not been demonstrated.”

See OPDP’s list of enforcement letters here

 

May 14, 2015

Update on the Medical Device Tax Repeal Efforts

Medical Device
 

The Medical Device Tax, instituted as part of the Affordable Care Act, is a tax of 2.3 percent on the sale price of medical device products. There has been considerable pushback against the tax—with members of Congress from both sides of the aisle arguing that it stifles innovation and costs jobs. While there has been a lot of talk about a repeal, the issue has seemed to stall until recently.  

In late April, the United States Senate Committee on Finance held a hearing entitled “A Fresh Look at the Impact of the Medical Device Tax on Jobs, Innovation and Patients.” In the lead-up to the hearing, Finance Committee Chairman Orrin Hatch (R-UT) stated that the Committee plans to mark up a bill to repeal the tax “soon,” notes Cooley Health Beat.  

The hearing itself is quite interesting. Senator Patrick J. Toomey (R-PA) started things off by holding up various medical devices—including a mechanical heart pump, a spinal implant, and a vagal nerve stimulator for epilepsy—all of which vastly improve patients’ lives but which took millions of dollars in losses to bring to market before ever showing a profit. The device tax only magnifies these losses. Toomey noted that at least one manufacturer, in order to offset the costs of the medical device tax, would be building its next factory outside the U.S. Further, the tax has cost jobs, as a number of speakers testified

Toomey also raised an important point when discussing how the tax works in practice:

My view is that the tax, the Medical Device Tax, is not only onerous on its scale, but it’s bad in its design. It is a tax on sales, not a tax on profits. And so these companies that I alluded to that spent large sums of money making these product and bringing them to market, they were losing money years, even when they started to have sales. The initial sales those years were not enough to be profitable. To impose a tax on those sales prior to there even being a profit, it just adds to the debt load that these companies have to carry. And there is only so much debt that can be financed. This is one of the concerns that I have. The design of this tax is very very unfortunate.

In the House: Protect Medical Innovation Act "prior to Memorial Day recess"

Even more recently, a group of 18 Democrats in the U.S. House of Representatives urged House leaders to pass H.R. 160, the "Protect Medical Innovation Act," that would repeal the device tax. The bill is sponsored by Rep. Erik Paulsen (R-Minn.) and Rep. Ron Kind (D-Wis). 

In a May 1 letter written by Rep. Scott Peters (D-Calif.) and co-signed by 17 other Democrats, the lawmakers said that the medical device tax is blocking new medical technology breakthroughs and ultimately harming patients. Furthermore, the tax is harming the employment outlook of a vibrant sector. “The medical technology industry directly employs over 400,000 Americans,” states the letter. “The industry is primarily comprised of small and medium-sized businesses and American companies representing 38% of the global market.” Importantly, “[o]f the 6,500 medical device manufacturers in the United States, 80% employ fewer than 50 employees," notes Peters. 

The letter was addressed to House Speaker John Boehner (R-Ohio), Minority Leader Nancy Pelosi (D-Calif.), Ways and Means Committee Chairman Paul Ryan (R-Wis.), and Committee Ranking Member Sander Levin (D-Mich.).He urged the House leaders to pass H.R. 160 by the Memorial Day recess. 

The sticking point in getting a medical device repeal has been the lack of a budget offset. Last year, the Joint Committee on Taxation estimated that the tax would raise about $28 billion over the next decade. H.R. 160 doesn’t include a way to offset that expected source of revenue. The White House has indicated that the President would veto a measure that doesn't account for the budget.

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