Al Caronia- a Former Jazz Sales Rep - the latest

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  1. Anonymous

    Anonymous Guest

    Dechert LLP Drug and Device Blog
    www.dechert.com
    www.druganddevicelaw.blogspot.com

    Caronia, The Latest

    Wednesday, August 31, 2011
    The moment we saw the Supreme Court’s First Amendment decision in Sorrell v. IMS Health
    Inc., 131 S. Ct. 2653 (2011), we knew it had implications for the FDA's suppression of truthful commercial speech concerning off-label uses, and we said so. Not only that, the dissent in Sorrell caught the FDA angle, too. Id. at 2678. Only the dissenters didn’t like it - we did.

    It appears that the first place that the Sorrell rubber is likely to meet the off-label promotion road is in our old friend, the Caronia case, which has been on appeal in the Second Circuit for what seems like forever. As readers may recall, Caronia was an FDA “sting” where a doctor, wearing a wire, affirmatively sought out off-label promotion, and (through the manufacturer's representative (Caronia)) drew another doctor (Dr. Gleason) who worked for a drug company, into a discussion of an off-label use. Both the other doctor, and the rep, who facilitated the conversation, were prosecuted. Nothing false was said, but the government went ahead anyway, and obtained a conviction.
    Caronia had already been argued after Sorrell was decided. The court (we think) on its own motion asked for additional briefing on Sorrell. Those briefs were filed this past week. The government’s brief - arguing in favor of criminal suppression of truthful promotion of off-label use - predictably takes the position that Sorrell doesn’t change anything. Since we like to gripe, we'll spend most of our time on that one.
    According to the government, the speech, even if truthful, wasn't itself banned, but was merely used as “evidence of intent.” U.S. br. at 1. Sorell was just more of the same, the government argued, simply another application of the Central Hudson test, and the court should ignore the Supreme Court’s references to “heightened" judicial scrutiny:

    “Read in this context, the Supreme Court’s references to “heightened judicial scrutiny” do not reflect a decision to abandon intermediate scrutiny in favor of a still more demanding level of judicial review. Instead, the term simply means a more rigorous form of judicial review than the rational-basis review employed by the First Circuit and urged by Vermont. The Court’s opinion makes clear that “heightened scrutiny” encompasses not only strict scrutiny, but intermediate scrutiny as well.”

    U.S. br. at 5. The Court’s “heightened” scrutiny reference “singles out,” the government claims, Cincinnati v. Discovery Network, Inc., 507 U.S. 410 (1993), which was a Central Hudson intermediate scrutiny case. U.S. br. at 5-6.

    The only trouble with that last statement is that it’s far less truthful than anything the
    defendants were prosecuted for in Caronia. We took a look at Sorrell, and Cincinnati was one of five, count ‘em, five cases cited to support the Court’s “heightened scrutiny” statement. See Sorrell, 131 S. Ct. at 2664. The other four, Turner Broadcasting System, Inc. v. FCC, 512 U.S. 622, (1994); United States v. Playboy Entertainment Group, Inc., 529 U.S. 803 (2000); Simon & Schuster, Inc. v. Members of New York State Crime Victims Board, 502 U.S. 105 (1991); and Minneapolis Star & Tribune Co. v. Minnesota Commissioner of Revenue, 460 U.S. 575 (1983), all suffer from the same problem, from the government’s perspective - they don’t even mention Central Hudson. So, by a Phillies-like 4-1 score, in the actual opinion, strict scrutiny prevailed over intermediate scrutiny.
    Next, the government argued that, even if more scrutiny than Central Hudson was required, it still doesn’t matter.

    Remember that. What that means is that, from now on, we're getting the government's position on so-called "strict scrutiny" - which is how restrictions on things such as
    political/religious speech are evaluated.

    The government's positions are positively retro - as in 1984.

    Under strict scrutiny, the would-be speech suppressors distinguish between a conviction for
    “conspiring to promote off-label uses” (supposedly not what happened) and a conviction for
    “conspiring to distribute [the drug] without adequate directions for use.” U.S. br. at 6. That’s a distinction without a difference. An ancient FDA regulation (substantively unchanged since the 1950s), 21 C.F.R. §201.128, equates one with the other. Promoting (truthfully or otherwise) off-label automatically changes the “intended use,” and the new “intended use,” since it’s off-label, by definition doesn’t have “adequate directions for use.” The government's position seems uncomfortably close to an argument that "conspiring" to advocate, say, medicinal marijuana, could be equated, through regulatory hocus-pocus, to selling pot.


    Building on its distinction without a difference, the government tries to describe the “adequate directions for use” language as creating some sort of “disclosure statute.” U.S. br. at 7. What would the government have these defendants disclose about off-label use? Somehow, we don’t think there’s any additional “disclosure” that either defendant could have made that would have kept them out of jail - the more they said, the more they would get into trouble. The only “disclosure” one can make about off-label use (if one works for an FDA-regulated company) is to say nothing. Disclosure = silence; love = hate. In another sleight of hand, the government argues that the prohibition is not “content based” for purposes of strict scrutiny because there is no “official hostility to the manufacturer’s message.” U.S. br. at 8. That’s contradicted, we suspect, by every Central Hudson brief the government has ever filed on the question of off-label promotion. Of course there’s “official hostility” to off-label promotion. It’s the “substantial government interest” that the government claims is advanced under the Central Hudson test. The FDA is institutionally opposed to off-label promotion because it believes that to allow such speech (truthful or otherwise) reduces the incentive for companies to get new uses approved by the FDA. The FDA's entire regime is
    based on “official hostility.” Off-label promotion strikes at the FDA’s bureaucratic raison d’être.

    Then the government inserts the other foot, claiming that its speech suppression isn’t even
    “speaker-based.” U.S. br. at 8. They put the man in jail, didn’t they? How more speaker-based can you get? Supposedly the FDA’s regulations aren’t “limited by their terms” to certain speakers, so they can constitutionally be used to convict particular speakers, even under strict scrutiny. Id. The government seems to believe that it can suppress speech all it wants if it does so vaguely enough. Oh, and if it’s not “speaker based,” how come everybody in the universe not affiliated with a regulated entity (even us, if we wanted) can put their uninformed two cents in on this or that off-label use, but only FDA regulated speakers (probably the most knowledgeable) can’t? That seems pretty “speaker based” - and dumb - to us.

    Next, the government offers the following “distinction” from Sorrell:“The Vermont law
    restricted the dissemination of information. In contrast [the federal act] requires it.” U.S. br. at 9. When we picked our jaws off the floor, we had to laugh. These defendants were convicted because they opened their mouths, not because they didn't. Later (in a different section of its brief), the government even states, “the court did instruct the jury that '[t]he manufacturer, its agents, representatives and employees, are not permitted to promote uses for a drug that have not been cleared by the United States Food and Drug and Administration.'” Id. at 12 (emphasis added). "Not permitted" sure sounds like a "restriction" on "dissemination" to us. Arguments like this - that the FDA’s total prohibition (outside of certain narrow categories) of off-label promotion is not a “restriction” on “dissemination” - is the kind of stuff that gives lawyers a bad name.

    The government next tries to scare the court by demonizing off-label uses. They are
    “unapproved,” “unproven,” and “potentially false.” U.S. br. at 10. But not actually false, and doctors engage in off-label use every day. We don’t know about this particular use, but the government - through Medicare/Medicaid - actually pays for a large number of off-label uses. The promotion of off-label use is no more unsafe or false (and probably less so) than the promotion of various “dietary supplements” we see us every time we turn on, say, the Weather Channel (which we did a lot recently).

    Then, after discussing non-First Amendment issues, the government circles back and goes after off-label use again. We see more scare tactics - using DES (used off-label to prevent miscarriage) as an example of a harmful off-label use. U.S. br. at 14-15. But DES was FDA approved without the “breast cancer” risk ever being discovered (it was before the 1962 FDCA amendments, for one thing). And, as defense lawyers in prescription drug products liability litigation, we’d be remiss if we didn’t point the number of on-label uses for drugs that the other side alleges cause breast cancer or other potentially fatal injuries.
    Certainly, there’s “no assurance” that an off-label use is safe or effective. U.S. br. at 16. But every drug on the market was originally an off-label use - before it was approved. That lack of “assurance” doesn’t make any particular use less safe the day before the FDA approves it, than it was the day after.

    Then the government states that the “new and qualitatively more reliable” information
    generated by FDA clinical trials “would never become available” if manufacturers could
    promote off-label uses. U.S. br. at 17. That’s not true, either. The FDA could easily abandon its speech-based prohibitions and simply mandate that off-label uses attaining some specified threshold of frequency must be submitted to the FDA for approval. Not only would that be more effective, it would suffer from no constitutional deficiencies.

    Finally, the government claims the FDA isn’t criminalizing “speech qua speech” because under the law it has to prove something else as well. U.S. br. at 20. What’s that something else that's supposedly sufficient to satisfy strict scrutiny? Introduction into interstate commerce. Id. Wow, if that’s all it takes to make any speech ban constitutional, I would hate to be a network broadcaster.

    Defendant Caronia also submitted a brief, pursuant to the court’s direction. Guess what? We like it better than the government’s brief. It emphasizes that the government’s parade of horribles simply isn’t implicated where the speech in question is true. “The “typical” neutral justification for “why commercial speech can be subject to greater governmental regulation than noncommercial speech” is the "concern for fraudulent or misleading statements in commercial transactions.” Caronia br. at 5. Sorrell, of course, was all about “truthful” speech. Id. at 9 (quoting Sorrell, 131 S. Ct. at 2671).

    Caronia then argues that the FDA’s suppression of truthful off-label promotion was “content
    based” and “speaker based” just as was the governmental attempt to restrict on-label detailing in Sorrell. Any other medical doctor would have been perfectly free to discuss off-label use with a colleague if not affiliated with a drug company. Caronia br. at 9. Like the detailers in Sorrell, a company-affiliated physician was within “a narrow class of disfavored speakers.” Id. And, like the restriction in Sorrell, it was also viewpoint based. If either of the defendants had said “don’t do that,” instead of “do that” (assuming that’s what happened), neither would have been criminally prosecuted. Id. at 9-10. We’d have hoped that was so obvious it didn’t have to be stated, but apparently it does. Nobody’s ever been prosecuted either for warning against off-label use (although in the past the FDA has sometimes taken the position, albeit not in court, that warnings are “promotion”) or for simply knowing about it without speaking.

    Caronia then equates the banning-too-persuasive speech rationale of Sorrell with off-label
    promotion, Caronia br. at 10, calling the similarities “striking.” Id. We probably wouldn’t go that far, because the FDA bans all off-label promotion, whether it’s persuasive or not, but we do agree fully that what was unconstitutional in Sorrell and the similar problem with the speech ban in Caronia stem from the same root - that pharmaceutical promotion is constitutionally protected speech. Nor is it just us being biased (which we freely admit to being) - as we mentioned at the beginning of this post, the Sorrell dissenters make the connection, too. Frankly, we think the off-label ban is worse (as does Caronia, br. at 11), because it’s criminal and because it’s more overtly tied to the content of the information than were the restrictions on use of data in Sorrell.

    And this just in - A group called the Medical Information Working Group also filed an amicus brief in Caronia. We want to get this post done, so as to the substance we'll just say "what they said." The MIWG brief is, in fact, closer to our First Amendment position than either of the parties' briefs, even Caronia's. What might be even more significant than the legal argumentsit makes, is the makeup of the MIWG - eleven major pharmaceutical companies. Finally, the big boys have had enough and are getting into the ring. Rather than let their rights be determined in appeals of criminal prosecutions selected by the government, we're hoping to see big pharma pick the First Amendment playing fields from here on out.

    Anyway, let's not forget that the Supreme Court in Sorrell resolved a First Amendment circuit split - affirming a pro-First Amendment ruling by the Second Circuit. It’s not lost on us that Caronia is also in the Second Circuit. We’re hoping that the Second Circuit, having received the Supreme Court’s good-jurisprudence seal of approval in Sorrell, sees fit to build on its First Amendment precedent in this area by reversing the conviction and holding unconstitutional the FDA’s outright suppression of truthful promotion of off-label uses.
    Finally, thanks to Rich Samp of WLF and attorneys at Ropes & Gray (representing MIWG) for providing us copies of the Caronia briefing - since PACER inexplicably doesn't include most appellate briefing.


    Dechert LLP Drug and Device Blog
    www.dechert.com
    www.druganddevicelaw.blogspot.com
     

  2. Anonymous

    Anonymous Guest

    The Wall Street Journal

    The Free Speech Pill

    By THOMAS M. BURTON

    Drug makers are mounting a legal campaign to overturn longstanding U.S. regulations prohibiting them from pitching medicines for uses not listed on the bottle.
    Doctors routinely prescribe such therapies as a hemophilia drug for brain hemorrhage, and cancer drugs for a wider array of tumors, in situations where federally approved medicines aren't believed as effective or simply don't exist.

    A pair of legal developments could let drug makers pitch products to treat ailments not listed on the medicine bottle, a practice long outlawed by federal regulators. Thomas Burton has details on Lunch Break.

    But drug companies can't market those uses thanks to decades-old restrictions from the Food and Drug Administration. Federal prosecutors have secured settlements totaling billions of dollars from companies including Pfizer Inc., AstraZeneca PLC and Eli Lilly & Co. for allegedly violating the rules.

    Now, several court cases and legal filings are threatening to erode that set of rules. Within weeks, a federal appeals court in New York is expected to decide whether Alfred Caronia, a former salesman for the company now known as Jazz Pharmaceuticals Inc. of Palo Alto, Calif., violated the law when he sold the narcolepsy drug Xyrem to treat other forms of drowsiness and chronic fatigue. He was convicted in a lower court on a criminal charge.

    But his case got a boost in June, when the U.S. Supreme Court cited the First Amendment in striking down a Vermont law that prohibited using pharmacy records in drug marketing. In its decision, the court wrote that speech used in drug marketing is a form of expression protected by the Free Speech Clause of the First Amendment. That opened the door for Mr. Caronia's attorneys to argue his off-label marketing was simply free speech.

    These and related legal developments "may put the FDA's ban on off-label promotion in some jeopardy," says Richard Cooper, a former FDA chief counsel now with Williams & Connolly in Washington.

    Wayne Pines, another former FDA official and a consultant to the drug industry, says "these cases raise fundamental questions about the way the FDA regulates marketing materials." Neither Mr. Cooper nor Mr. Pines is involved in these cases.

    The drug industry has made the free-speech argument before, and there is no certainty the New York appellate court will get to the constitutional issues or that the case will go on to the Supreme Court. But the direction of the current Supreme Court—and its willingness to introduce the First Amendment in striking down such laws—could alter the regulatory landscape, lawyers say.

    Big drug makers, emboldened by decisions of the high court, have jumped into the Caronia appeal. In a "friends of the court" brief, and in other legal actions around the U.S., the industry is challenging the FDA on the rules more forcefully than before.
    In the brief, Pfizer, GlaxoSmithKline PLC, Johnson & Johnson and eight other companies wrote that "off-label use is a necessary and common practice," and that applying the FDA's off-label rules to Mr. Caronia's alleged conduct "appears to be constitutionally indefensible" given the Supreme Court ruling.

    A group of seven big drug companies filed a July petition with the FDA contending that the rules' "lack of clarity places manufacturers at risk of criminal and civil sanctions if they cannot correctly guess where the government would draw a line."

    Whatever happens in Mr. Caronia's case, it's too late for his co-defendant, Maryland psychiatrist Peter C. Gleason. He gave paid talks for Jazz and pleaded guilty to a federal off-label marketing charge. The Annapolis doctor hanged himself in February. His sister Sally Goodson, says her brother's suicide "was directly because of this case."

    The Caronia case is squarely focused on off-label marketing, and his lawyers have raised the First Amendment defense. The federal appeals court judges in New York have asked for briefs on how the Supreme Court decision affects their case.

    Last month, Par Pharmaceutical Inc. sued the FDA and Department of Justice in federal district court in Washington, arguing that free-speech principles bar the FDA's off-label rules. Par has said in a court filing it wants to market Megace, a drug approved to treat AIDS-related weight loss, at long-term care facilities that also house cancer and geriatric patients.

    Thomas W. Abrams, director of the FDA's Division of Drug Marketing, Advertising and Communications, says the off-label rules are in place for safety reasons.

    "FDA does not want pharmaceutical companies promoting something as safe and effective when that hasn't been proven," he says. "Think of someone you love the most. Would you want that person on a drug that's not proven simply because the drug was promoted in such a way?"

    He cites the example of estrogen. It was sold for decades as beneficial to heart health, but more recent research shows a complex mix of danger and benefit, depending in part on the age of the woman using it. The FDA is concerned that heavy marketing for unproven uses will multiply the number of people exposed to danger.

    Medtronic Inc.'s bone-growth protein Infuse has been widely used off-label by orthopedic surgeons, doctors say. But in 2008, the FDA warned that its off-label use in neck spine operations had led to life-threatening swelling in the neck and throat that caused difficulties swallowing and breathing. Medtronic says it included warnings about Infuse use in the neck prior to 2008 and said it is committed to further research on the product.

    Many off-label uses haven't triggered safety concerns. Government reports and medical journal articles have estimated that half or more cancer patients receive off-label drugs because studies required for drug approval can take so long. Yet companies cannot market for these uses.


    Companies have paid a high price over the last two decades for allegedly violating off-label marketing rules. Of 31 drug cases settled under the False Claims Act from 1996 through 2010, 15—totaling $8.7 billion—involved off-label or fraudulent marketing and the related charge of misbranding, according to a September article in Archives of Internal Medicine.
    In the largest such case, Pfizer agreed in 2009 to plead guilty to a federal criminal charge of illegally marketing the painkiller Bextra off label and to pay $2.3 billion for illegally promoting it and other drugs.

    Write to Thomas M. Burton at tom.burton@wsj.com
     
  3. Anonymous

    Anonymous Guest

    What Jazz did to Dr. Gleason and Al was disgusting. We never hid the fact that we were calling on docs for fibro and for Jazz to pretend that they had no clue when they bought Orphan is a joke. They knew it and when the feds came a calling the witch hunt ensued.......anything to protect the Jazz name. What has happened since with the price of Xyrem is practically unethical. When I was selling it Xyrem cost about $7000 per year and even then it was considered expensive. Now, according to the new VP of marketing it's up to $41,000 per year (listen to the earnings call http://investor.jazzpharma.com/phoenix.zhtml?p=irol-eventDetails&c=210227&eventID=4221926) and that's just six years later. You current reps may kid yourself that the patient does not actually pay that and there are various programs in place to ensure that there is free or low cost supply but its baloney. Someone is paying and thats the insurance companies and who eventually pays their bills - you and me.
     
  4. Anonymous

    Anonymous Guest

    Jazz is collecting most of its payments of $40,000 a year plus from Medicaid and Medicare and th V.A. -- the taxpayer. Since most people with narcolepsy cannot afford insurance which would pay for Xyrem, they are often forced to go on disability to receive their meds. So Jazz is actually on the dole -- collecting most of their fees from the these agencies. Those with insurance live in fear their insurance will either be cancelled or the Xyrem prescription not allowed. Jazz admits its increased profits are primarily from price increases, not more people taking the medication. Xyrem was originally developed as an orphan drug (one not expected to generate profits) with substantial government assistance in its development by Orphan Medical, a company that received the 1997 corporate award for outstanding service to the rare disease community from NORD. Jazz merely bought the drug, intending to extend its usage to fibromyalgia and thus, to reap huge profits. They collected millions from investors, even preselling its European distribution rights. But they were turned down by the FDA with a 20-2 vote. Then they began to raise their prices in earnest. Physicians tell us it can be manufactured for a few dollars a month and some desperate narcoleptics intend to try to make it on their own. Why -- because it is the only one that works for most people with narcolepsy. Jazz must be held accountable. Why doesn't the US govt understand the need to regulate drug prices or even take over the distribution of "unprofitable" orphan drugs?
     
  5. Anonymous

    Anonymous Guest

    http://druganddevicelaw.blogspot.com/search/label/First%20Amendment

    Drug and Device Law

    Friday, November 04, 2011

    You Heard It Here First

    Yesterday's Wall Street Journal has an interesting article about the FDA's off-label promotion ban being "in some jeopardy" after the Supreme Court's Sorrell decision, and pointing to the Caronia case, to be decided "within weeks," as the leading example of possible First Amendment scrutiny. Well, you heard it here first. We pointed out this implication of Sorrell back in June, the day that the Supreme Court decided the case. We've been following Caronia even longer. Glad to see the mainstream media waking up, that the government ability to monetize (to the tune of over $8 billion, according to the article) its First Amendment violations may be drawing to a long-overdue close.
     
  6. #6 Anonymous, Nov 6, 2011 at 9:05 AM
    Last edited by a moderator: Aug 12, 2016 at 11:44 PM
    Anonymous

    Anonymous Guest

    Bill died for nothing. Dr. Gleason, rest his soul should have held on a little longer. Too bad such a good doc was sacrificed. Has Jazz ever contacted his family? Sent condolences?
    Bill's family was paid over 1 million. Bet they got a condolence letter.