Life Science Compliance Update

May 21, 2015

21st Century Cures Act Passes 51-0 in House Energy and Commerce Committee

21ST CENTURY

This morning, the House Energy and Commerce Committee voted 51-0 to approve the 21st Century Cures Act. With the way the bipartisan bill sailed through, it appears the 21st Century Cures train has left the station.

The Act was authored by full committee Chairman Fred Upton (R-MI), Oversight and Investigations Subcommittee Ranking Member DeGette, full committee Ranking Member Frank Pallone, Jr. (D-NJ), Health Subcommittee Chairman Joe Pitts (R-PA), and Health Subcommittee Ranking Member Gene Green (D-TX). 

"This historic day marks a big bipartisan step forward on our path to cures,” said Upton. “We have all said too many early good-byes to people we love and treasure. Every single person has a common goal: we want more time with those we love. In this, the greatest country in the world, Americans deserve a system second to none. We can and must do better. The time for 21st Century Cures is now.” 

"In the last century, American medicine leapt from medicine shows to the mapping of the human genome,” said DeGette.”With the 21st Century Cures Act, we seek to support the biomedical community in making a similar leap forward in this next century. With billions in support for our premier research and development institutions and comprehensive reform of our systems, 21st Century Cures will make a real difference in the lives of patients and their families." 

Rep. Green added, “I’m proud of the final bill that was voted out of Committee, which will improve the innovation ecosystem for the development of life-saving medical breakthroughs, foster the development and the interoperability of health information technology, and better leverage critical resources to facilitate the discovery of new cures. After one year of deliberation, research, and stakeholder input we’re one step closer to delivering new cures and therapies, and hope to patients.”

After the voting, Congressman Joe Barton (R-TX) expressed his enthusiasm for the fact that the Cures bill was unanimous:

I’ve been on the Committee for 28 years, and I don’t think we’ve ever had a major bill that didn’t have somebody...that voted no. That is an amazing accomplishment Mr. Chairman, and I think the Committee should congratulate you, Mr. Pallone, Ms. DeGette, Mr. Pitts, and all the other members who worked in a leadership role.

This is a real achievement. This will change America. This will change the world for the better. This will last. This bill will become law and it will last for decades.

That is a real achievement.

 

The 21st Century Cures Act is full of important provisions, including a number of issues regularly covered on Policy and Medicine.

Encouraging Continuing Medical Education for Physicians

Section 3041 would exempt certain transfers of value to physicians from Sunshine reporting requirements that physicians have indicated hinder them from participation in important continuing medical education activities.

Section 2101:  Facilitating Dissemination of Health Care Economic Information

This section would add clarity and facilitate dissemination of health care economic information, as defined in the section, to payers, formulary committees, or other similar entities.

Section 2102:  Facilitating Responsible Communication of Scientific and Medical Developments

This section would require FDA to issue guidance on facilitating responsible, truthful, and nonmisleading scientific and medical information not included in the label of drugs.

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John Kamp, the Executive Director of the Coalition for Healthcare Communication, called 21st Century Cures "a great step forward for American patients." Andrew Rosenberg of the CME Coalition notes that Congress "has demonstrated the commitment to CME as a bipartisan issue." 

We will continue to provide updates to the 21st Century Cures Act progress as it moves through the House and Senate. 

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

 

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