The drugmaker is on what it calls a transparency kick. Having already created registries listing clinical trials and grants, Lilly is apparently the first big drugmaker to back the Physicians Payments Sunshine Act, which would establish a national registry of payments to docs by drug and device makers.
Drug and device makers have been under pressure to take such steps. You may recall a dozen drug and device makers last month told Chuck Grassley, the Iowa Republican and a co-sponsor of the bill, that they would publicly disclose grants to outside groups, and the details will be provided on each company’s web site. And as part of a settlement with the Department of Justice, five device makers agreed to post consultant payments on their web sites.
In a statement, Herb Kohl, a Wisconsin Democrat and the other co-sponsor of the legislation, praised Lilly. “Eli Lilly’s endorsement goes to show that transparency of the financial ties between doctors and drug makers is not only sensible, but do-able,” says Kohl.
“Lilly…believes this legislation represents an important step in building public trust and confidence in the relationships between the pharmaceutical and device industries and physicians,” John Lechleiter, Lilly’s newly promoted ceo, in a statement. “This will help provide the assurance that Lilly runs its business consistent not only with our principles, but with the principles that a healthcare provider or patient should expect from a pharmaceutical company.”
Lilly, however, has stopped short of full disclosure in some cases. Its grant registry doesn’t contain any listings before 2007. And as we noted last October, its clinical trial registry doesn’t list Phase IV trials completed before July 1, 2004. And while the Cialis web site boasts about safety and effectiveness in 22 trials, not all show up on the Lilly trial registry. You can read about that here.
We our about to take a rare midday break to speak at the Healthcare Compliance Packaging Council annual meeting. But we do promise to return shortly with the usual menu of items. Meanwhile, we came across these headlines. See you soon…
Pfizer To Close Indiana Plant & Shed 140 Jobs (Yahoo/AP)
Moody’s Cuts Amgen Ratings (MarketWatch)
Hank McKinnell Joins Angiotech Board (The Wall Street Journal)
AstraZeneca’s Toprol Raises Risk Of Death: Study (Bloomberg News)
Intercell To Buy Iomai For $189 Million (Yahoo/Reuters)
A coming wave of Chinese pills is set to push down generic prices, as more low-cost finished meds from China win approval in major markets, Reuters reports, citing an IMS Health study.
You may recall that China is already the world’s biggest producer of active pharmaceutical ingredients, but so far hasn’t been a significant supplier of finished generic pills. But last year’s first FDA approval of a Chinese generic - a copy of the Viramune AIDS drug - indicates a big change is coming.
At least 10 other Chinese companies are set to follow suit, Reuters writes, and some could be available as early as this year, causing increased competition for the generic industry. “In order to ensure their success in the market, the Chinese manufacturers are likely to undercut all others on price,” IMS wrote. “Chinese policy will drive generic prices down still further, with far-reaching consequences for both R&D players and international generic companies.”
Read more »
Last February, the controversial gadfly and former Pfizer exec cleared a hurdle in his ongoing whistleblower lawsuit against Pfizer. In a filing, Rost cited approximately 200 instances in Indiana which Genotropin, a human growth hormone, was marketed by Pharmacia (which was bought by Pfizer) for unapproved uses, such as combating aging in adults and treating short stature in children.
Providing such detail was needed for the case to proceed. And the move signaled two potentially significant developments. One is the long-term implication for Pfizer, should Rost ultimately prevail. The other is that his efforts may serve as a template for other whistleblowers who are similarly stymied by federal judges seeking details that are, otherwise, very hard to come by.
Pfizer, however, last month turned around and argued that fraud was not involved because Genotropin was listed in three major pharmaceutical compendia, such as Drugdex and the US Pharmacopeia, which meant that state Medicaid programs would likely be required to issue reimbursements anyway. (These is a lot of background reading, but if you wish to do so, please look here, here and here).
Now, though, the Department of Justice, which declined to join Rost’s case, has taken a position favorable to Rost by filing a statement of interest, citing concerns with overall interpretation of law. (Look here). The motion is significant, because the DOJ essentially rebuts the key points Pfizer is using to get the case dismissed. By doing so, this may increase the likelihood that the case will proceed toward discovery.
Read more »
A funny thing happened on the way to the US Supreme Court this week - a few justices had to recuse themselves from a case because they held stock in companies with a matter before the court. Justice Samuel Alito, for instance, holds shares in Bristol-Myers Squibb.
This was the second recent instance in which a Supreme Court justice took this step. Two months ago, Chief Justice John Roberts sat out a case involving lawsuits against Pfizer because his May 2007 financial disclosure form indicated he held Pfizer stock between $10,000 and $50,000.
This raises a potentially interesting situation come fall. The court will review a preemption case involving Wyeth. At issue is the notion that FDA approval supercedes state law claims challenging safety, efficacy, or labeling. Drugmakers and the FDA argue preemption exists by maintaining agency actions are the final word on safety and effectiveness.
The court’s ruling will determine whether patients can sue a drugmaker through state law when a product has already been approved by the FDA. Given the high stakes, we wonder if Alito and Roberts will recuse themselves from the Wyeth case, even if they do not hold Wyeth stock. In other words, if a Supreme Court Justice has holdings in any drugmaker, should they not recuse themselves? What do you think?
Loading …
Every so often, we like to try something different on this evolving site. And so once again, we are running what amounts to a guest column. Why? We like the idea of livening up the usual menu of items with input from a loyal reader, but also one who has experience in the trenches and a refreshing point of view. Will we do this again? Maybe. We do not wish to be flooded with requests, but we are open to suggestion. Meanwhile, we hope you enjoy this little contribution…
Securing America’s Pharmaceutical Supply Chain
by Adam Fein, who is president of Pembroke Consulting and who blogs about pharmaceutical distribution issues on his Drug Channels site.
The political response to the tragic Heparin situation has now begun in earnest. While pointing our finger at China seems easy, it is highly misleading to link contamination of an ingredient to the equally pressing concerns of stopping counterfeit finished goods from infiltrating the legitimate pharmacy supply chain. America’s approach to tracking finished drugs in the pharmaceutical supply chain needs a radical overhaul.
Thankfully, counterfeits drugs are still extremely rare in the US. Legislators should recognize that the Heparin situation does not represent the most common way in which a counterfeit drug could enter your neighborhood pharmacy. Instead, it’s much more common for a counterfeit drug to slip into the system when someone buys from an unreliable secondary source or intentionally counterfeits or compromises an authentic medicine. This process has been the entry point for almost every case investigated by the FDA in which a counterfeit or adulterated drug ended up in your local pharmacy. We cannot be complacent.
Read more »
Concerned about how antipsychotics are being used in children, Washington state officials are working on a plan due by early fall to ensure the meds are properly prescribed for kids on Medicaid, The Tacoma News-Tribune reports. “The data is concerning,” Jeff Thompson, chief medical officer for the state Medicaid program, tells the paper.
State data, in fact, show the use of atypical antipsychotics in children enrolled in Washington’s Medicaid program for low-income people increased about 25 percent between 2004 and 2007. Last year, 4,978 Medicaid participants 18 or younger were taking the drugs, and 187 were 5 or younger. Some were on two or more drugs at the same time.
The most recent data available show that the state Medicaid program spent about $9 million last year on the drugs for children 18 or younger, up from $4.96 million in 2004. Stats on use of the drugs in Washington children not taking part in Medicaid are unavailable, the paper adds.
Read more »
A seemingly arcane legal concept is quickly gaining a great deal of attention - and for good reason. At issue is the notion that FDA approval supercedes state law claims challenging safety, efficacy, or labeling. Drugmakers and the FDA argue preemption exists by maintaining agency actions are the final word on safety and effectiveness.
This fall, the Supreme Court will hear a case - which involves a Wyeth drug (here’s the back story) - and the ruling will determine whether patients can sue a drugmaker through state law when a product has already been approved by the FDA. To get in front of the issue, the House Committee on Oversight and Government Reform will explore the debate.
The witness includes some marquee names - actor Dennis Quaid, who is suing Baxter; former FDA commish David Kessler, who opposes preemption and New England Journal of Medicine editor Greg Curfman, another preemption opponent. In fact, several of the eight witnesses appear not to be crazy about preemption. And there’s no one from pharma to schedule to appear, which would make for a lively discussion.
In any event, we hope to offer a live webcast when the hearing gets under way at 10 am EST, so do stop by and watch Henry Waxman in action. (He chairs the committee).
The FDA continues to be slow in sending warning or untitled letters when the agency suspects drugmakers violated DTC rules, according to a report by the Government Accountability Office, FDAnews reports.
Last year, the agency took an average of six months to issue regulatory letters citing DTC violations, Marcia Crosse, who heads the GAO’s healthcare division, told a House subcommittee last week. In one case, the agency took more than three years to issue a regulatory letter, FDAnews notes.
Before 2002, when the FDA decided that all draft warning or untitled letters had to undergo legal review — a policy for which there was no apparent need — it took less than a month to send such letters, Crosse told the committee. (Here’s her testimony).
The FDA hasn’t improved since 2006, when the GAO found that “by the time the agency issued regulatory letters, drug companies had already discontinued use of more than half of the violative advertising materials identified in each letter,” according to the latest GAO report accompanying Crosse’s testimony. “In addition, FDA’s issuance of regulatory letters had not always prevented drug companies from later disseminating similar violative materials for the same drugs.”
Read more »
As both Kano State and the Federal Government resume their legal battle against Pfizer over the antibiotic clinical trial in 1996, which allegedly killed 200 children in Kano, there were strong indications during the weekend that the parties to the case might settle out of court, according to a report on AllAfrica.com, citing intervention by a respected traditional ruler from Kano State.
Meanwhile, an unnamed source in the Kano State attorney-general’s office said despite “exaggerated claims in many media stories” regarding the children who allegedly suffered death or injury in the study, the Kano government cites 57 names in its amended criminal complaint, which means that 143 patients - nearly three-fourths of all the patients in the study - were not included in the complaint.
“So based on the government’s own assessment, we are talking only about 57 patients, and there are many doubts and question marks about these,” the source stated.
Read more »
