Today's Top Stories
Does the FDA have a weak link? The House Committee on Oversight and Government Reform is asking the agency whether its office in Puerto Rico has been understaffed and under-performing, given recent drug-manufacturing problems found on the island.
Sent by Reps. Edolphus Towns and Darrell Issa, the letter points out the ongoing problems with drugs made at a Johnson & Johnson ($JNJ) plant that manufactured consumer drugs subject to a series of recalls. And it raises questions about serious manufacturing shortfalls at a GlaxoSmithKline ($GSK) plant; the company recently agreed to pay $750 million to settle claims involving substandard manufacturing there.
Puerto Rican facilities were also involved in Pfizer's ($PFE) recent recalls of moldy-smelling Lipitor. Bristol-Myers Squibb ($BMS) has had ongoing problems at a facility in Manati, in-Pharma Technologist points out. And, according to Bloomberg, drug plants on the island failed their FDA inspections 64 percent of the time from 1999 to 2010--and 70 percent of the time since 2007.
So, the committee is asking for FDA documents, including a list of the Puerto Rican sites overseen by the agency, a list of its inspections performed over the past 10 years, and copies of warning letters issued for Puerto Rican facilities. "It appears that FDA's Puerto Rico district office may be having difficulty exercising oversight on the numerous pharmaceutical manufacturing facilities on the island," Issa and Towns wrote. The FDA says it will respond when it receives the letter.
- see the New York Times coverage
- get more from Bloomberg
- see the in-Pharma Technologist story
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Read more about: Puerto Rico, FDA
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This week's sponsor is World Congress.
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The U.S. government has just added its weight to the tug-of-war over generic versions of Lovenox. Momenta Pharmaceuticals ($MNTA) won the high-stakes race to sell its generic form of the Sanofi-Aventis ($SNY) blood thinner earlier this year, in partnership with the Novartis ($NVS) copycat drugs unit Sandoz. But that OK came only after conflict-of-interest accusations from other generics makers also seeking FDA approval for their Lovenox knock-offs.
As Amphastar Pharmaceuticals and Teva Pharmaceutical Industries ($TEVA) saw it, Momenta had a too-cozy relationship with CDER Chief Janet Woodcock in particular and the FDA in general. During the heparin scandal in 2008, Momenta pitched in on the investigation at no charge--at the same time the agency was considering its application to sell a Lovenox copycat. The agency investigated and recently announced that Woodcock had no financial conflicts in the generic-Lovenox review.
Now, however, Congress' watchdog group, the Government Accountability Office, says the agency's actions made it appear to show favoritism to Momenta, even if it really didn't. Momenta's free consulting work, coming at the same time as its application review, "ran the risk of undermining public confidence in the integrity of FDA's operations," the GAO says in a new report obtained by the Wall Street Journal.
Responding to GAO's report, the FDA told the Journal that it needed Momenta's help in identifying the source of heparin contamination that killed or seriously injured more than 100 people. But, the agency said, it should have considered the appearance of conflict--and should have done more to disclose the possibility.
- get the story from the WSJ
- see the Reuters news
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Read more about: Momenta Pharmaceuticals, lovenox
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The cancer-drug gold rush has slowed. For the first nine months of this year, sales of oncology meds rose by only 3.5 percent, compared with 9 percent for all of 2009--and that was down from 14 percent in 2007 and 23 percent in 2006. And as IMS Health SVP Murray Aitken tells Reuters, this year's growth was driven mostly by price increases.
As Reuters points out, 2006 was when Roche launched Avastin, a revolutionary drug that targeted cancer in an entirely new way. Although drugmakers have plowed lots of investment into cancer-drug development, recent introductions have been variations on existing therapies rather than brand-new innovations. And as some targeted therapies go off patent, spawning generic competition--think Sanofi-Aventis' Eloxatin, which lost IP protection this year--those copycats are drawing off sales.
"This is an unprecedented slowdown," Aitken said at the Reuters Health Summit. But he went on to say that the slowdown can be reversed. "If we had another Avastin or Herceptin, it would quickly change direction," he said.
- read the Reuters story
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Read more about: cancer drugs, Avastin
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As public scrutiny of the financial ties between drugmakers and doctors has grown over the last few years, more physicians have backed away from gifts and payments from the pharma industry. That's the conclusion of a new report from the Mongan Institute for Health Policy, which found that 84 percent of docs accepted freebies, samples and speaking fees last year, compared with 94 percent in 2004.
Published in the Archives of Internal Medicine, the survey shows that skeptical attitudes toward pharma-physician relationships--exemplified by new conflicts-of-interest policies at some medical schools and teaching hospitals--are having an effect on doctors' behavior, the lead author told Bloomberg. The biggest change: CME payments and junkets, which dropped to 18 percent from 35 percent. "The data clearly show that relationships have dropped dramatically," said Mongan director Eric Campbell.
The study also found that doctors with industry relationships do tend to prescribe more brand-name drugs than those without such ties. Plus, U.S. regions with the lowest medical costs also have fewer gift-accepting doctors, the survey showed. "[W]hile the drug representatives tell the doctors that these gifts mean nothing," Campbell said, "studies show that accepting anything of value, even things of essentially no value, establishes a reciprocity between the person who gives the gift and the one who receives it."
PhRMA told the Los Angeles Times that many of the industry-doctor links are perfectly appropriate, such as drug samples. The industry association has slightly tightened its voluntary guidelines for relationships between physicians and pharma. And several Big Pharma companies have started disclosing their financial ties to physicians, including Eli Lilly, Merck and GlaxoSmithKline.
- read the Bloomberg coverage
- get more from Hospital Review
- see the Archives study abstract
- check out the LA Times piece
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Read more about: Conflict of interest, Payments, doctors
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Genzyme ($GENZ) and Sanofi-Aventis ($SNY) are once again trading barbs in their ongoing contest over Sanofi's hostile bid. But the most intriguing remarks about that potential deal today came from the sidelines.
First, the companies themselves: Sanofi released a letter urging Genzyme to abandon any defensive tactics suggested by management, including adopting a new poison-pill provision. "[I]n all fairness, you should allow your shareholders the opportunity to decide for themselves," CEO Chris Viehbacher wrote. Genzyme fired back with its own letter reiterating its contempt for Sanofi's $18.5 billion offer, once again saying that its sales-and-earnings forecasts show the company is worth much more.
But here's the rub, offered by Novartis. The Swiss drugmaker questions those very sales forecasts, predicated as they are on rosy projections for future sales of Genzyme's experimental multiple sclerosis drug Campath. Novartis just won FDA approval for Gilenya, an MS treatment that would compete with Campath, and its development chief says that drug will capture enough of the market to keep Campath sales below Genzyme's $3 billion target.
"$3 billion was probably realistic in May, but is it realistic now?" asks Trevor Mundel (as quoted by Reuters), saying that Gilenya will be the first-line drug, leaving Campath to compete for second-line status. "To the extent that we solved the first-line issue first, then space for Campath will close down."
Meanwhile, a key biotech investor says Genzyme has virtually no chance of remaining an independent company. Some 40 percent to 50 percent of the company's shares are now held by arbitragers, who are betting on a takeover. "Genzyme is history," Frederick Frank, vice chairman of Peter J. Solomon, said at Reuters' health conference. "It's only a question of when and at what price."
- see the Genzyme release
- read the Bloomberg story
- get more from the Wall Street Journal
- check out the Reuters coverage
- find another take from Reuters
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Genzyme mulls Campath giveaway for cancer patients
Sanofi chief unswayed by Genzyme forecasts
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Novartis CEO 'fairly confident' Gilenya will top $1B
Novartis pill poised to rattle MS market
Read more about: multiple sclerosis, Gilenya, Novartis, Sanofi-Aventis
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@FiercePharma: J&J chief talks up plans for rehabbing image.