No aBLA Biosimilar

09/22/2010 04:39 PM |

Much discussion at the Business of Biosimilars conference today about the evils of evergreening.  Purity, potency and safety?  Feh.

Other topics of heated debate centered around whether or not “biobetters” would always precede biosimilars (most thought so) and whether or not that was a good thing. (Different points of view depending on whether you’re looking at it from a developer, payer or provider standpoint.  (Hint – there weren’t any providers in the room.)

And there seemed to be general consensus that, with a clear FDA pathway still off in the future, BLAs are the way to go.  Hence a redefinition of BLA as “Beat Legislative Ambiguity.” No aBLA biosimilar.

Badges?  We don’t need no stinking badges.

Two interesting comments from Leigh Purvis (Senior Strategic Policy Advisor, AARP). The first was that the folks at AARP are concerned that “biologics will soon be used to treat paper cuts.”  (Nice to reconfirm where they stand on the issue.) And the second that, while it’s important to educate AARP members about both generics and biosimilars –“there isn’t any money available in the budget.” 

Draw your own conclusions.

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A funny thing happened on the way to the forum (on biosimilars)

09/21/2010 04:22 PM |

A funny thing happened on my way to the Business of Biosimilars conference in Boston -- a draft document about a two-day FDA public hearing on FOBs began making the rounds.

 

According to the draft, the hearing will take place on November 2^nd and 3^rd and, potential changes notwithstanding, provides insight into the future of FDA-regulated biosimilars.

 

"The purpose of this public hearing," the document states, "is to create a forum for interested stakeholders to provide input regarding the agency’s implementation of the statute concerning the following issues, among others: 

 

* Scientific and technical factors related to a determination of biosimilarity or interchangeability; 

 

* The type of information that may be used to support a determination of biosimilarity or interchangeability; 

 

* Development of a framework for optimal pharmacovigilance for biosimilar and interchangeable biological products;

 

* Scope of the revised definition of a  “biological product”; 

 

* Priorities for guidance development;

 

* Scientific and technical factors related to reference product exclusivity; 

 

* Scientific and technical factors that may inform the agency’s interpretation of “product class” as it relates to available regulatory pathways for certain protein products during the 10-year transition period following enactment of the BPCI Act; and 

 

* The establishment of a user fee program for biosimilar and interchangeable biological products."

 

An ambitious agenda for two-weeks or two months – let alone two days.  But, you’ve got to start somewhere.

 

And none too soon if the frustration, confusion, angst and agita (pardon the mixed ethnography) at the Boston confab is any indication of the larger issues in play.

 

And from the “Use That Gavel While You’ve Got It” department, draft legislation unveiled Monday (courtesy of Representatives Henry Waxman, Frank Pallone, John Dingell, and Bart Stupak) aimed at boosting the FDA's authority to monitor the sale of prescription drugs, which increasingly occurs on a global scale.

"Americans have been alarmed in recent years over some very concerning issues related to the quality and safety of certain drug products. We know we need to address this. The only question now is how," Dingell said in a statement.

 

The draft legislation would require "parity" between inspections of foreign and domestic drug manufacturing plants. Now, overseas production sites are inspected much less often than U.S.-based facilities. It also would require that manufacturers "ensure the safety of their supply chain" and would give the FDA power to mandate recalls of unsafe medicines.

 

Dingell stated, "Americans have been alarmed in recent years over some very concerning issues related to the quality and safety of certain drug products. We know we need to address this. The only question now is how."

 

“How,” it seems, is the order of the day.

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And the hits keep on coming

09/21/2010 10:39 AM |

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Of stimulus and stimulants

09/20/2010 12:20 PM |

As seen in the Atlanta Journal Constitution:
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Avastin Avowal

09/17/2010 01:45 PM |

From today's edition of Reuters' "Great Debate" series:

Let cancer patients have this pill

By:  Peter J. Pitts

One more day — or week, or month, or perhaps even a year. It may not seem like much time, but patients with incurable cancer know better. For Christi Turnage of Mississippi, who lives with stage IV breast cancer, it means seeing her daughter start kindergarten, celebrating her 27th wedding anniversary, and watching her sons graduate from college.

Her family and her oncologist credit her quality of life for the past two years to the drug Avastin, a biologic that combats cancer by cutting off the blood supply to tumors. But advanced breast cancer patients like Turnage have been forced to spend precious time battling something else: the possibility that federal regulators will vote today to remove approval of Avastin for their treatment.

If officials with the U.S. Food and Drug Administration are wise, they will overrule the agency’s cancer-drug advisory panel, which voted 12-to-1 last month to recommend denying a valuable clinical option to advanced breast cancer patients. According to the Department of Health and Human Services, an estimated 40,000 women die from breast cancer each year.

The panel concluded that the costly drug doesn’t eke out enough extra lifetime among breast cancer patients to justify its use and risks. This ignores all the “super responders” — the patients who reap significant benefits from Avastin. Scientists have no way of identifying these people in advance, and they could be devastated if they are denied the medicine.

“This is not a worthless drug by any means,” Eric Winer, director of the Breast Oncology Center at the Dana-Farber Cancer Institute in Boston. “There is almost certainly a group of women who get a big benefit.”

Indeed, the Susan G. Komen for the Cure and Ovarian Cancer National Alliance – recently sent a joint letter to the FDA urging the government to keep it as a choice best made by a woman and her doctor.

The groups also warned that if the FDA de-lists Avastin for breast cancer, it would only discourage future drug development.

Two years ago, the FDA fast-tracked approval of Avastin for metastatic breast cancer two years ago, and since then it has been prescribed to about 17,500 women a year with the disease. The drug, which earned FDA approval for the treatment of colon, lung, kidney and brain cancer, is the world’s best-selling cancer drug.

A clinical trial that took place from December 2001 and May 2004 found that Avastin boosted the amount of time that breast cancer patients lived without the disease spreading or worsening. The drug in combination with chemotherapy delayed tumor growth for about 11 months, which was more than five months longer than chemo alone. Follow-up studies indicated a less robust response, yet still found an average delay in tumor growth to between one and three months.

But even if Avastin does not, “on average,” extend life for breast cancer patients, that  “average” is composed of patients who respond in dramatically different ways –including some like Christi Turnage who gain years.

Another is retired California art teacher Patricia Howard, who reports that infusions of Avastin every three weeks over the past two years have shrunk tumors in the lining of her lung and eliminated fluid that hampered her breathing. Now she enjoys shopping and golf, and describes her life as “beyond fabulous.”

Serving as a patient representative at the FDA’s last session, Howard recalled, “One doctor got up during the meeting and said ‘This drug gets women only to first base and we want a home run.’ I felt like jumping up and saying I don’t mind just being in the ballgame.”

If the FDA does remove approval of Avastin for breast cancer, doctors conceivably could write prescriptions for it anyway, going “off label.” But it’s likely that Medicare and private insurers would not cover the cost of what is one of the world’s most expensive drugs. Patients could continue Avastin only if they could afford $8,000 a month out of pocket.

Avastin is a better alternative than the status quo for breast cancer patients, and can be truly transformative for some. No wonder Avastin-users are desperately writing letters, circulating petitions and, like Turnage’s 19-year-old son Josh, posting videos on  YouTube pleading their case.

Avastin is their last hope. The FDA should make sure it is not their lost hope.

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Joint Relief?

09/17/2010 08:08 AM |

(Reuters) - A new process to review medical products at the U.S. Food and Drug Administration in tandem with the nation's Medicare insurance program could help speed up coverage decisions, the FDA said in announcing the move on Thursday.

Under the proposal, the FDA would review and make approval decisions alongside the Centers for Medicare and Medicaid Services, which decides whether and how to pay for new medical products for its elderly and disabled patients once they are approved for the U.S. market.

To start, the agencies proposed a pilot project for devices after both FDA and CMS had time to review public comments on the proposal.

More than 45 million people are covered under the Medicare program. Private insurers often weigh CMS's coverage decisions when setting their own reimbursement policies, and a decision by Medicare to cover a new product can speed its adoption in the wider marketplace.

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Decomposing Obamacare

09/16/2010 01:58 PM |

The diehard supporters of Obamacare consist of the bloggers and wonks who said ramming the bill down the throats of the American people would pay dividends because people would fall in love with the legislation after it was passed.

This litte group of elites guessed wrong.  Poll and after poll shows that not is Obamacare wildly unpopular but it remains a principal reason for voters to toss out Democrats in November.

Yet, the elites still insist that the law is popular:

"A new CBS/New York Times poll has found that 49 percent of Americans oppose the health care law, compared with just 37 percent who support it.
ObamaCare booster Jonathan Cohn, while acknowledging that recent polls have been discouraging, sees some silver lining in the CBS/NYT poll. He notes that "While 40 percent of respondents said they supported repealing the Affordable Care Act, more than half changed their minds (leaving just 19 percent in favor of repeal) when pollsters mentioned that it'd mean letting insurance companies exclude people with pre-existing conditions."


What a hypocrite.   As Phil Klein of the American Spectator points out:

"Yet this is the same argument that proponents of the legislation have used all along to explain poor poll results -- that it's more popular when you ask separately about its component parts. The problem is that the popular parts are linked to other less popular parts to make up the whole."

spectator.org/blog/2010/09/16/opposition-to-obamacare-rises

Moreover, Cohn and others have always insisted that you can't provide such exemptions without forcing everyone to buy into government approved plans and using price controls and rationing to control use of services.  You can't have it both ways: point to support of changes people are in favor of yet insist that the entire law in its current form must be implemented.     If pollsters mentioned other aspects of the bill -- as an earlier CMPI poll showed --  support evaporates.

The fact is, repealing the worst features of Obamacare and replacing it with something that gives people coverage, choice and control over health care decisions is something a vast majority of Americans favor.

pajamasmedia.com/files/2010/03/CMPIA.PJM-raw-data.pdf

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More research for the anti-vaccine zealots

09/16/2010 11:45 AM |

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Eli's Coming

09/16/2010 09:29 AM |

Eli Lilly & Co, that it is ... to the wonderful world of the healthcare policy blogosphere.  Their new blog "LillyPad" can he found here.

Hoosier daddy?
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Is David Graham Off His Cracker?

09/15/2010 12:57 PM |

David Graham's latest black helicopter theory about the fact that an FDA advisory committee recommended keeping  Avandia on the market (with additional warnings) with editorial comments from Steve Nissen:

Silver Spring, MD - Accusations of bias among the FDA advisory committee that voted on the fate of rosiglitazone (Avandia, GlaxoSmithKline) earlier this summer have been made by two members of the FDA's Office of Surveillance and Epidemiology [1].

In a letter to BMJ published online September 7, 2010, Drs David Graham and Kate Gelperin point out that half the members of the July 2010 advisory panel had previously voted in favor of allowing rosiglitazone to stay on the market at an earlier FDA advisory committee in 2007. They write: "In an unprecedented move, the FDA's Center for Drug Evaluation and Research (CDER), which originally approved rosiglitazone and has defended its continued marketing, invited not only the current members of these committees [the Endocrinologic and Metabolic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee] but also all members from the 2007 meeting, even though they were no longer active members of either committee. Of the 32 advisers who voted at the 2010 meeting, 16 (50%) attended the 2007 meeting, and 15 of them had voted that rosiglitazone remain on the market (one attendee was a temporary nonvoting invitee)."

Graham and Gelperin say this biased the vote at the 2010 meeting. They calculate that members voting for the first time were 4.4 times more likely to vote that rosiglitazone be withdrawn from the market than were members who had voted previously to keep it on the market. "Had these former members not been included, the vote would have been 10 out of 17 (59%) in favor of rosiglitazone withdrawal, with an additional three in favor of severely restricted distribution," they add.


Panel "loaded"?

Commenting on this for heartwire, Dr Steve Nissen (Cleveland Clinic, OH), the coauthor of the meta-analysis at the center of the rosiglitazone safety concerns, who has been leading the campaign to get rosiglitazone withdrawn, said it was obvious that the 2010 panel was "loaded."

They have rigorously defended rosiglitazone again and again, and obviously they feel they cannot be seen to have made such an error.
He added: "The outcome of FDA advisory panels is significantly influenced by who is on the panel. When I saw the roster, I knew it was going to be an uphill struggle. I was very surprised that they had invited back people who had already voted to keep the drug on the market in 2007. Once you have opined publicly, it is very difficult to turn around and admit you made a mistake." Nissen said it would have been the leadership at the CDER that decided who to invite to this panel meeting, and this is another demonstration they do not want to act against this drug. "They should have acted much earlier on, when the first negative data were reported. But they have rigorously defended rosiglitazone again and again, and obviously they feel they cannot be seen to have made such an error."

Here are my questions:

Why does BMJ feel compelled to help Graham and Nissen peddle their fearmongering?  And where is the opportunity to provide an opposing (and more balanced) view?

Why are the two launching an attack on FDA's integrity now?  Does it have anything to do with yet another campaign to pressure the agency to overturn the Ad Comm decision?

Does Nissen actually believe that the composition of the Ad Comm is part of a CDER coverup?  That is a very serious accusation.  Did St. Steven the Pure wear a wire when talking to CDER officials?

www.theheart.org/article/1121701.do

Oh, and one more question:  What about the recent observational study showing no difference in heart risks between Avandia and Actos.  No comment or BMJ editorial yet from Nissen or Graham, a study that, uniike Graham's did not use data dredging to squeeze out an 18 percent additional risk of heart problems associated with Avandia compared to Actos.. 

circoutcomes.ahajournals.org/cgi/content/short/3/5/538



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Papal No Bull

09/15/2010 06:37 AM |

Agenzia Fides, the missionary press agency of the Vatican, has spoken out against counterfeit drugs

 

and the approximated 700,000 people expected to die annually due to their pervasiveness.

 

Fake tuberculosis and malaria drugs alone are estimated to kill 700,000 people a year. A large part of these victims are African. The World Health Organization (WHO) estimates that up to 30 percent of the medicines on sale in many African countries are counterfeit and have found that nearly half of the drugs sold in Angola, Burundi, and the Congo are substandard.

 

In 2003, Interpol conducted a survey on the quality of drugs available in Lagos, sub-Saharan Africa's most populous city and found that 80 percent of the drugs available were fakes. In 2008, more than 80 children in Nigeria died after being given medicine for teething pain that was laced with antifreeze.

 

Fake medicines can be missing key ingredients, use the wrong ingredient, or have insufficient or too much of the active ingredient. In some cases, use of these medicines can increase drug resistance. When there is not enough of the active ingredient, the drug kills some of the parasites or viruses, but the pathogens that are not killed adapt. As time goes on, even if a patent was to be treated with the correct medication, he or she would not be cured.

 

Agenzia Fides states, “The development of germs resistant to antibiotics and other treatments is a problem that affects all humanity, not just Africans. It is therefore in the best interest of all concerned that smuggling of counterfeit drugs be fought against.”

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Is Change Inevitable?

09/14/2010 11:17 PM |

"Change is not required," wrote marketing guru W. Edwards Deming.  "Survival is not mandatory."

Which brings us to the FDA and the future of medical innovation.

A few years ago I had the honor of discussing both topics with Nobel Prize Laureate Joshua Lederberg.  Actually, to be accurate, I mostly listened and took notes at the feet of the great man.

When I asked him about FDA's role in 21st century medical science, Dr. Lederberg responded that the real question should be, "Is innovation even possible?"

To that end, have a look at this very interesting and challenging cover story from this week's edition of BioCentury.  Titled, "Regulatory Innovation," it makes some keen observations and offers some siginificant food for thought.

Is innovation even possible?  Let's hope so.


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REMS as the cure for antibiotic resistance?

09/14/2010 08:08 AM |

In an upcoming position paper the Infectious Diseases Society of America suggests that overuse of antibiotics could be controlled via a REMS-like approach – or even an actual REMS.  

Interesting idea, because something new must be done. The problem of antibiotic resistance is a real, urgent, and relatively silent public health crisis.  For those who rant about the influence of DTC advertising on the doctor/patient dialogue -- it doesn't even hold a candle to a parent's plaintive plea for a prescription when their child has an ear ache.

In the past, FDA has worked with the CDC on consumer education programs such as “Cough, Sniffle, Sneeze – No Antibiotics, Please."  But such efforts have met with only modest success (and that’s being generous).

If it takes a REMS to drive the safe and appropriate use of antibiotics, then so be it.  Burdensome on docs, yes – but they have nobody to blame but themselves. 

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Dating Advice From Pharmalot

09/13/2010 01:52 PM |

Last Chance to Register: How to Avoid Meeting a Federal Prosecutor Get expert insight from... Michael Loucks - Former U.S. Attorney; Partner, Healthcare Enforcement & Litigation, Skadden Arps Ed Silverman - Editor, Pharmalot on how to work within brand promotion regulations and avoid litigation. TOMORROW, September 14, 2010 12:00 p.m. ET | 9:00 a.m. PT REGISTER NOW - SAVE $25 ONLY $124 PER PERSON/$474 FOR YOUR ENTIRE TEAM! (enter promotional code Fed42)

TO BE FOLLOWED BY CMPI'S OWN SEMINAR:  TIPS ON HOW TO DATE A DRUG REP
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The False Profits of Fake Medicines

09/13/2010 08:18 AM |

Counterfeit medicines are a real problem – and quantifying that problem is, well, a real problem.  How do you estimate criminal activity in ways other than a body count? “Show me the dead Canadians” (as Senator Bernie Sanders is so fond of saying) is not an excuse to do nothing. And purposely derailing the international fight against the false profits of fake medicines via the spanner of "definition" is unconscionable. 

Here are four excellent new articles (two from the Wall Street Journal, one from USA Today and the fourth from the Washington Post) that remind us that counterfeit medicines are an important public health issue here at home and around the world.

The first WSJ piece can be found here, the next here, the USA Today story here and the Post’s take here.

While counterfeits are tough to measure, it doesn’t mean that we can ignore the problem.  To belittle the problem because we cannot substantiate the volume is unwise.  If we wait to count the bodies – we have only ourselves to blame.

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Canada vs. California on child vaccinations

09/11/2010 01:58 AM |

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A man of many positions…on health care reform

09/10/2010 12:23 PM |

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Criminalizing Cough Medicine?

09/09/2010 01:26 AM |

This turns unauthorized sale or use of said cough medicines into an illegal activity. And it means that law enforcement professionals and educators have to devote time and effort investigating and arresting kids who violate the new FDA rule.

I think it is silly to pursue this approach. In the first place, making something prescription does nothing to limit abuse. Indeed, the sharing of prescribed medications is rampant. Secondly, there are other OTC medications that cause many more problems than cough medicines with DXM. That being the case, why not put every OTC that is abused back into prescription or behind the counter. Let's start with aspirin, Vivarin, Red Bull. Why not just ban everything that could possibly lead to adverse events or dependency.

Our poll shows that the first responders and the adults who interact with kids daily (teachers) have bigger issues. Before deciding to require the policing of another medication because it was in the news, the FDA should consider the perspective of those who already have responsibilities for keeping our kids safe. Instead of regulating in this instance the FDA could be educating about the safe and proper use of all medications.

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L Shana Tova

09/08/2010 03:03 PM |

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Some New Year's Wisdom from the Tevi Fountain

09/08/2010 07:45 AM |

Obama's biological countermeasures
By: Tevi Troy
 
President Barack Obama announced in his State of the Union address “a new initiative that will give us the capacity to respond faster and more effectively to bioterrorism or an infectious disease — a plan that will counter threats at home and strengthen public health abroad.”

Eight months later, Health and Human Services Secretary Kathleen Sebelius has come out with a report launching the initiative. It does not just call for additional spending, as most federal initiatives seem to do, but for a reconsideration of our life science development process, with a specific call for clearing up bottlenecks that hold up new countermeasures to combat a host of biological threats.

In trying to move the report from paper to policy, the administration may find that some of its most implacable opponents are its staunchest allies, while putative allies may cause the administration heartburn.

“The review repeatedly revealed that aspects of the current regulatory framework and unmet need for regulatory science present both perceived and real barriers for developers seeking to enter the MCM arena,” the report found. In other words, companies looking to create new lifesaving products find the product development process both intimidating and difficult.

To address this, according to the accompanying HHS press release, “HHS will make a significant investment to provide FDA scientists with the resources to develop faster ways to analyze promising new discoveries and give innovators a clear regulatory pathway to bring their products to market.”

There is little doubt that bureaucratic hiccups and “bottlenecks,” as the report calls them, make the development process for new medical products — including drugs, vaccines, biologics and devices — longer than it needs to be. It takes about 10 years and $1 billion to bring a new pharmaceutical product to market, making such an investment only available to large or well-funded entities. One longtime career staffer told me while I was HHS deputy secretary that he never understood why industry complained about the Food and Drug Administration until he began working on trying to develop and acquire new countermeasures through BARDA, the Biomedical Advanced Research and Development Authority, which manages Bioshield.

Two years ago, I produced an HHS report detailing strategies to approach bottlenecks in the life science development process, which I shared with the incoming administration.

It is noteworthy, however, that a Democratic administration is coming up with these findings, as criticizing pharmaceutical companies has become a staple Democratic attack. Both John Kerry in 2004 and Barack Obama in 2008 sent barbs their way, and congressional Democrats such as Henry Waxman have long been critical of the companies as well.
 
Many congressional Democrats, as well as other Pharma critics on the left, will not want to embrace Sebelius’ drive to clear up FDA bottlenecks — and they may be uncomfortable with the funding for the countermeasure enterprise as well.
 
The new administration initiative calls for $2 billion in funding as “Democrats on Capitol Hill have tried repeatedly to cut funding for the BioShield program to pay for other domestic priorities,” according to Congressional Quarterly’s Julian Pecquet. If the House succeeds in its efforts to cut $2 billion out of this area, the new initiative could be scuttled before it even gets off the ground.

It also is interesting that the report somehow fails to acknowledge the administration that made the greatest strides in encouraging the development of our current countermeasures.

The report notes that “the federal government began work over a decade ago, during the Clinton administration, to develop and stockpile medical countermeasures against biological threats.” Although the report acknowledges Bill Clinton by name, things that happened in the most recent decade are characterized by a sentence saying that “events after Sept. 11, 2001 led to an acceleration of those efforts.” These efforts included, as the report acknowledges, a new smallpox vaccine, the purchase of anthrax antibiotics and vaccine, and countermeasures against botulinum toxin.

Other important developments recognized by the report include the creation of Project Bioshield for development and procurement of countermeasures and the creation of the pandemic flu preparedness plan. Both were major achievements of the Bush administration, as were the creation of a new HHS office of preparedness and response, as well as BARDA itself.

The report’s inartful and passive “after Sept. 11” construction appears to be a kind of Soviet method for referring to actions undertaken by the Bush administration without actually mentioning George W. Bush’s name. The Obama administration may be loathe to acknowledge this, but in calling for clearer regulatory pathways and more funding for developing and acquiring medical countermeasures, it may be angering some key allies, as well as embracing an important part of the Bush legacy.  Read More & Comment...