The proponents of academic detailing are making another push again. It seems like we’ve been hearing this same drone from Boston for the last 15 years. But now they’ve got Senator Herb Kohl (D-WI) and a few other Democrats lined up to push an appropriations bill in Congress. The proponents need more funding to prove their hypothesis doesn’t work. Let me explain.
Prescription Project and Community Catalyst have been claiming there are savings in the Pennsylvania test case of academic detailing, but have been unable to actually demonstrate it. They have produced one “study” which relies on future “accounting projections,” but they cannot quantify any actual savings now. This is the same kind of fuzzy math that has gotten dozens of states into trouble recently as the economy turned sour. And yet the proponents of academic detailing persist in their claims despite the face they have no objective research that is independently verifiable and they were unable to articulate these costs savings during a town hall in Philadelphia back in April. They are long on rhetoric and short on facts.
Ironically, despite the claims of Prescription Project and others, The Independent Drug Information Service (the group that administers the Pennsylvania program) is quite cautious in its assessment of financial savings. In fact, the website takes great pains to carefully avoid making any claims of actual savings to the Commonwealth of Pennsylvania. In press release hyping the program, Robert Restuccia makes sweeping claims about other countries employing academic detailing and the vast sums of money those countries have saved. Incidentally, the Independent Drug Information Service mentions the same thing, but indicates only that other countries have tried the program, but there is no mention of savings.
Harvard’s Dr. Jerry Avorn, the father of academic detailing and the brains behind the Independent Drug Information Service, has admitted under oath in Federal Court that to effectively implement academic detailing it would require billions and billions of dollars. And even then, it is probable that academic detailing will remain an ideal that is unlikely to ever succeed, is unlikely to ever generate any real savings, and is unlikely to ever drive down drug prices. So why do it?
The answer: So Herb Kohl can show his brilliance! If you give people the impression you are actually doing something, it's just as good as actually doing something. Get the AARP crowd to focus on academic detailing so Kohl and the elite club in Washington don't actually have to tackle the major issues facing healthcare.
Hat tip to Pharmalot
Thursday, July 31, 2008
Sunday, July 27, 2008
Cancer’s Big Pink Problem
The passing of Randy Pausch, Carnegie Mellon University professor and author of “The Last Lecture,” on Friday and my own recent health ailments have me thinking a lot about life and death. While I have a lot to say on that particular subject, I would like to focus instead on the disease that took Dr. Pausch’s life – pancreatic cancer.
The National Cancer Institute (NCI) puts the 2008 incidence of 37,680 with deaths at 34,290. The 5-year survival rate for pancreatic cancer is almost zero (in real terms). New pharmacotherapies like Tarceva (from OSI Pharmaceuticals and Genentech) and Erbitux (ImClone Systems) have both had some clinical success with pancreatic cancer, but more options are needed. Cancer vaccine trails into pancreatic cancer have all but come to standstill after the debacle and controversy surrounding the FDA’s bungling of Dendreon’s Provenge.
In contrast, the NCI puts new 2008 breast cancer incidence at 182,460 (female) and 1,990 (male). Breast cancer deaths are estimated at 40,480 (female) and 450 (male). The 5-year survival of breast cancer (even with metastatic disease) is very good. There are dozens of options and combinations for treating breast cancer and all have very good outcomes.
Why such inequalities? Pancreatic cancer is very different type of cancer. It is more difficult to detect and much more difficult to treat. The other answer lies in sociology – the squeaky wheel gets the grease.
Despite being more of killer (as a percentage of incidence), pancreatic cancer is vastly under researched compared to breast cancer. The number of treatments is much more limited and clinical pipeline is radically smaller. Few people with pancreatic survive long enough to go on and form and establish advocacy organizations and conduct educational outreach. Without those compelling patient stories, pancreatic has become the invisible cancer. Randy Pausch’s very visible, moving and vocal advocacy has been the exception in pancreatic cancer, not the rule.
Breast cancer is the cancer of choice for celebrity endorsements and mega-charities like the Susan G. Komen Breast Cancer Foundation. Susan G. Komen took in over $207 million for fiscal year 2006 (the most recent year for which its financials are available). In stark comparison, the Pancreatic Cancer Action Network took in just $7.3 million (2007 financial data). Susan G. Komen wastes more money in a year than goes to pancreatic cancer research and education (Susan G. Komen spent over $15.2 million on fundraising alone; almost $18 million on administrative functions and the organization had a budgetary excess of $17.7 million).
I don’t fault Susan G. Komen for what they have achieved. There was a time when breast cancer needed the kind of visibility that Komen brought. That time has passed and Susan G. Komen has become a perpetual charity – growing to grow and existing to exist. The organization is more about the status of hot pink than it is about breast cancer.
But the silent killer of pancreatic cancer needs attention too. If your company is being extorted to participate in yet another Susan G. Komen event, consider opting out. Susan G. Komen is well funded and doesn’t need your money, but other diseases and other charities could really use your support.
It’s sad that cancer research and support has to be a zero-sum game, but it is. Every dollar into the pockets of Susan G. Komen means that research isn’t being done into other cancers – other cancers that have far higher mortality rates. Don’t believe the media hype of the Susan G. Komen PR army, it’s time to let the hot pink go and focus on cancers that actually killing mothers and fathers in America. Mothers like my aunt Marilyn, who lost her battle to pancreatic cancer years ago. And fathers like Randy Pausch, who leaves behind three young children.
The National Cancer Institute (NCI) puts the 2008 incidence of 37,680 with deaths at 34,290. The 5-year survival rate for pancreatic cancer is almost zero (in real terms). New pharmacotherapies like Tarceva (from OSI Pharmaceuticals and Genentech) and Erbitux (ImClone Systems) have both had some clinical success with pancreatic cancer, but more options are needed. Cancer vaccine trails into pancreatic cancer have all but come to standstill after the debacle and controversy surrounding the FDA’s bungling of Dendreon’s Provenge.
In contrast, the NCI puts new 2008 breast cancer incidence at 182,460 (female) and 1,990 (male). Breast cancer deaths are estimated at 40,480 (female) and 450 (male). The 5-year survival of breast cancer (even with metastatic disease) is very good. There are dozens of options and combinations for treating breast cancer and all have very good outcomes.
Why such inequalities? Pancreatic cancer is very different type of cancer. It is more difficult to detect and much more difficult to treat. The other answer lies in sociology – the squeaky wheel gets the grease.
Despite being more of killer (as a percentage of incidence), pancreatic cancer is vastly under researched compared to breast cancer. The number of treatments is much more limited and clinical pipeline is radically smaller. Few people with pancreatic survive long enough to go on and form and establish advocacy organizations and conduct educational outreach. Without those compelling patient stories, pancreatic has become the invisible cancer. Randy Pausch’s very visible, moving and vocal advocacy has been the exception in pancreatic cancer, not the rule.
Breast cancer is the cancer of choice for celebrity endorsements and mega-charities like the Susan G. Komen Breast Cancer Foundation. Susan G. Komen took in over $207 million for fiscal year 2006 (the most recent year for which its financials are available). In stark comparison, the Pancreatic Cancer Action Network took in just $7.3 million (2007 financial data). Susan G. Komen wastes more money in a year than goes to pancreatic cancer research and education (Susan G. Komen spent over $15.2 million on fundraising alone; almost $18 million on administrative functions and the organization had a budgetary excess of $17.7 million).
I don’t fault Susan G. Komen for what they have achieved. There was a time when breast cancer needed the kind of visibility that Komen brought. That time has passed and Susan G. Komen has become a perpetual charity – growing to grow and existing to exist. The organization is more about the status of hot pink than it is about breast cancer.
But the silent killer of pancreatic cancer needs attention too. If your company is being extorted to participate in yet another Susan G. Komen event, consider opting out. Susan G. Komen is well funded and doesn’t need your money, but other diseases and other charities could really use your support.
It’s sad that cancer research and support has to be a zero-sum game, but it is. Every dollar into the pockets of Susan G. Komen means that research isn’t being done into other cancers – other cancers that have far higher mortality rates. Don’t believe the media hype of the Susan G. Komen PR army, it’s time to let the hot pink go and focus on cancers that actually killing mothers and fathers in America. Mothers like my aunt Marilyn, who lost her battle to pancreatic cancer years ago. And fathers like Randy Pausch, who leaves behind three young children.
Tuesday, July 22, 2008
Roche to Acquire Genentech (Again)
Swiss-based Roche has announced its intention to acquire the rest of biotech firm Genentech, in which Roche already has a majority stake. The consolidation makes a degree of sense given the ongoing redundant operations (and cost centers) in the two organizations.
The financial markets, news organizations and other bloggers like Pharmalot all seem surprised by this announcement. While the timing is a certainly a bit of surprise, the announcement itself isn’t.
When Severin Schwan took the helm about a year ago, it was widely suspected that he wanted to make his mark at the Basel-based giant by bringing Genentech fully into the fold. At a large meeting of Roche employees in Basel last September, Schwan was asked whether Genentech will remain an independent entity. At that time, his answer was ‘for now,’ although everyone in the meeting was left with the distinct impression that ‘for now’ meant ‘not for long.’
The relationship between Roche and Genentech dates back to 1990s when Roche purchased a majority stake in the company. Roche has had rights to acquire the remaining shares. In 1999, Roche required Genentech to redeem all of its outstanding special common shares not owned by Roche. Roche then re-listed Genentech and conducted several subsequent stock offerings.
The relationship between Roche and Genentech has been a productive one for both over the years. The collateral damage and employee defections in both organizations (here in the U.S. as well as overseas) could destroy the one thing that has given them a competitive advantage over time – their people.
The financial markets, news organizations and other bloggers like Pharmalot all seem surprised by this announcement. While the timing is a certainly a bit of surprise, the announcement itself isn’t.
When Severin Schwan took the helm about a year ago, it was widely suspected that he wanted to make his mark at the Basel-based giant by bringing Genentech fully into the fold. At a large meeting of Roche employees in Basel last September, Schwan was asked whether Genentech will remain an independent entity. At that time, his answer was ‘for now,’ although everyone in the meeting was left with the distinct impression that ‘for now’ meant ‘not for long.’
The relationship between Roche and Genentech dates back to 1990s when Roche purchased a majority stake in the company. Roche has had rights to acquire the remaining shares. In 1999, Roche required Genentech to redeem all of its outstanding special common shares not owned by Roche. Roche then re-listed Genentech and conducted several subsequent stock offerings.
The relationship between Roche and Genentech has been a productive one for both over the years. The collateral damage and employee defections in both organizations (here in the U.S. as well as overseas) could destroy the one thing that has given them a competitive advantage over time – their people.
Thursday, July 17, 2008
Medicare Football
It’s been a fun week in Washington, D.C. The on-again, off-again, back on-again legislation known as the Medicare Improvements for Patients and Providers Act of 2008 has been in the air. Congress, true to their word, promptly picked up the legislation (also known as the American Medical Association Handout Act of 2008) after returning from the Independence Day recess.
The legislation was a certainty, but Congress made if official on Tuesday. The bill passed both chambers but was vetoed by President around 1:30 on Tuesday. The House then voted to override by the comfortable margin of 383-41. The Senate picked up the legislation around dinner and picked up a few more votes, overriding Bush’s veto by 70-26.
Docs get another 18 months. Although, as interesting as this way, I find it remarkable that NOBODY in Washington actually wants to touch the issue of permanently fixing this annual fiasco and benchmarking physician payments to inflation. The silence in Washington is enough to give me hope that physician costs may one day be subjected to same stringent cost cutting measures we’ve seen in other aspects of healthcare.
The legislation was a certainty, but Congress made if official on Tuesday. The bill passed both chambers but was vetoed by President around 1:30 on Tuesday. The House then voted to override by the comfortable margin of 383-41. The Senate picked up the legislation around dinner and picked up a few more votes, overriding Bush’s veto by 70-26.
Docs get another 18 months. Although, as interesting as this way, I find it remarkable that NOBODY in Washington actually wants to touch the issue of permanently fixing this annual fiasco and benchmarking physician payments to inflation. The silence in Washington is enough to give me hope that physician costs may one day be subjected to same stringent cost cutting measures we’ve seen in other aspects of healthcare.
Tuesday, July 15, 2008
The Toll of Chronic Disease
In healthcare (at least in the U.S.), there are two conflicting forces: managing disease and controlling cost. While trying to control cost, we manage the symptoms of disease. So instead of helping people be well, we focus on helping them be less sick. Semantics? Not really. In the lives of most patients this distinction is real. The toll of chronic disease isn't dollars - it is pain and disability and recognition that your "normal life" is gone.
This was brought home for me today by two new surveys out today from Centocor and the GeneRAtions program. The surveys looked at 1,000 RA patients as well as 300 physicians to understand the human impact of disease on people's daily lives. People with RA:
This was brought home for me today by two new surveys out today from Centocor and the GeneRAtions program. The surveys looked at 1,000 RA patients as well as 300 physicians to understand the human impact of disease on people's daily lives. People with RA:
- Felt feelings of sadness or depression on average every 1 day in 4
- Had difficulty with normal activities every 1 day in 3
- 90% indicated that RA impacted their ability to perform their jobs over the last three months
- 60% felt that their friends and family underestimated the severity of the disease on their lives
- 50% felt that their doctors did not fully understand the impact on their lives
"It's difficult to explain to people, even as a former Olympic athlete, why I sometimes struggle because of my RA. Many people don't understand how great the mental and physical challenges can be when living with this condition," said Joy Fawcett, Olympic gold medalist and retired member of the U.S. Women's Soccer Team. "I'm fortunate that in the 10 years since my diagnosis, education and treatment for the disease have improved, but we need to continue this momentum."
RA isn't a death sentence and can be treated with medication. Yet, in the interest of controlling costs, we make patients live through years of hell and prior authorizations just to get to the drugs that will help them be well (not just less sick). We see this trend play out in other diseases as well, notably diabetes and asthma. The pound foolish Medicaid plan or insurance company is happy to let the patient go for a $2,000-$5,000 visit to the emergency room instead of paying the $200 a month for medication.
Physicians need to focus on caring for their patients, not just treating them. And patients need to empower themselves to be well, not just less sick.
Sunday, July 13, 2008
The Indian Pharmaceutical Industry
A lot of energy and effort is going into ensuring the supply chain of drugs from China. The FDA has a proposal to begin stationing inspectors in China as soon as next year.
But I’ve been noticing a growing trend of problems with the Indian pharmaceutical industry. A huge proportion of the world’s active pharmaceutical ingredients (API) come from India. Over the years, Indian firms haven’t been content merely to provide API, they are now manufacturing finished products.
The growing number of Indian firms comes with a dark side. These Indian firms seem to have a culture of compliance problems, fraud and endangering patient’s lives. It’s become so problematic that the Indian Pharmaceutical Association uses the motto “A crusade for professionalism.” In India, there have been ethical problems with many different companies, but now the flagship of the Indian pharmaceutical industry – Ranbaxy – has stumbled…badly.
Ranbaxy is one of the major powerhouses in the manufacture of generic drugs for the U.S. market. Ranbaxy has global sales of over $1.4 billion dollars and was the 19th largest manufacturer (by prescriptions) according to IMS Health in 2007. Yet, according to papers filed by the U.S. Government, Ranbaxy has committed a “pattern of systemic fraudulent conduct.” The Government asserts that the generic drugs manufactured by Ranbaxy were not identical to the original branded products because they were either too weak, too strong or lacking the required stability to considered identical to the original branded product. I’ve been saying it for a long time and Ranbaxy just proved it – generic drugs are not identical to the original products (contrary to rhetoric of the Generic Pharmaceutical Association). Generics are usually “close enough” or “similar enough” to the originals, but in the case of Ranbaxy, they weren’t. It is unclear exactly how many patients were possibly harmed or even killed through exposure to Ranbaxy products.
The problems are not limited to India alone. A number of companies operating in the U.S., but founded by individuals from India have been plagued by these same problems. These companies include Scientific Laboratories (see Another Contract Firm Impodes) and the infamous case of Able Laboratories.
It would be unfair (and irresponsible) of me to say that all problems in the industry are from firms with Indian origin, or that all Indian firms are committing criminal acts. However, even a casual observer of the pharmaceutical industry couldn’t help but notice this trend. As quickly as the FDA has moved to crack down on problems in China, they should be moving even faster in India – the lives of millions of people depend on it.
Source: DNA
But I’ve been noticing a growing trend of problems with the Indian pharmaceutical industry. A huge proportion of the world’s active pharmaceutical ingredients (API) come from India. Over the years, Indian firms haven’t been content merely to provide API, they are now manufacturing finished products.
The growing number of Indian firms comes with a dark side. These Indian firms seem to have a culture of compliance problems, fraud and endangering patient’s lives. It’s become so problematic that the Indian Pharmaceutical Association uses the motto “A crusade for professionalism.” In India, there have been ethical problems with many different companies, but now the flagship of the Indian pharmaceutical industry – Ranbaxy – has stumbled…badly.
Ranbaxy is one of the major powerhouses in the manufacture of generic drugs for the U.S. market. Ranbaxy has global sales of over $1.4 billion dollars and was the 19th largest manufacturer (by prescriptions) according to IMS Health in 2007. Yet, according to papers filed by the U.S. Government, Ranbaxy has committed a “pattern of systemic fraudulent conduct.” The Government asserts that the generic drugs manufactured by Ranbaxy were not identical to the original branded products because they were either too weak, too strong or lacking the required stability to considered identical to the original branded product. I’ve been saying it for a long time and Ranbaxy just proved it – generic drugs are not identical to the original products (contrary to rhetoric of the Generic Pharmaceutical Association). Generics are usually “close enough” or “similar enough” to the originals, but in the case of Ranbaxy, they weren’t. It is unclear exactly how many patients were possibly harmed or even killed through exposure to Ranbaxy products.
The problems are not limited to India alone. A number of companies operating in the U.S., but founded by individuals from India have been plagued by these same problems. These companies include Scientific Laboratories (see Another Contract Firm Impodes) and the infamous case of Able Laboratories.
It would be unfair (and irresponsible) of me to say that all problems in the industry are from firms with Indian origin, or that all Indian firms are committing criminal acts. However, even a casual observer of the pharmaceutical industry couldn’t help but notice this trend. As quickly as the FDA has moved to crack down on problems in China, they should be moving even faster in India – the lives of millions of people depend on it.
Source: DNA
American Red Cross and J&J Settle Logo Lawsuit
As I predicted, the American Red Cross was all but victorious in its dispute over the logo – a red cross. If you’ll recall, Johnson & Johnson sued the Red Cross over using the logo on products, claiming J&J owned the trademark. The American Red Cross is older and has been using it for longer than J&J…a fact missed by J&J attorneys. This wasn’t about who actually owned the rights to the logo (J&J knew it belonged to the Red Cross). This was an intimidation campaign by a large company hoping to scare a non-profit into backing down. In the game of chicken, the Red Cross didn’t flinch and J&J had to deal with a monumental mess.
Well, the suit is over and the American Red Cross comes out smell like a rose. The judge initially tossed a number of J&J’s complaints and now J&J has dropped the suit realizing it wouldn’t win (either in the court of law…or public opinion). Of course, nothing like this ever goes away quietly and the J&J press release lacks any real facts (read the joint press release here). I was in Europe at the time this came out and missed it, but found the little blurb on the JNJBTW blog…where the company has been doing all of their communicating on the issue.
However, there are a couple of lessons here:
- First, this is a case study example in how to create a PR disaster. J&J fumbled the ball on the first play (filing the lawsuit while the entire PR team was “on vacation”) and couldn’t recover. Fire the lawyers or fire the PR team, but somebody screwed up big time.
- Second, for a company that prides itself on a credo, this was a stupid thing to do. I don’t think Johnson & Johnson will ever recover their image on this one. And the sound you hear is the goodwill of the Tylenol crisis going down the drain.
This was a costly mistake for J&J. It has tarnished the image of once good company. And rumor on the street is that J&J now needs to pay the legal bills of the American Red Cross…and pony up a substantial donation to the organization.
The lawsuit may be settled, but repairing the damage to the company has only just begun.
Also see:
- If Tylenol Happened Today
- J&J’s Red Cross PR Mess
- Red Cross 1, J&J 0
- Johnson & Johnson Moves to Profit on Clara Barton Name
- J&J Expands Red Cross Lawsuit
- How the Mighty Have Fallen: Johnson & Johnson
- J&J’s PR Gaffe Continues
- Red Cross Sued by J&J
Tuesday, July 8, 2008
The Quest for Synthetic Blood
If at first you don’t succeed, try and try again. And Biopure is trying and trying and trying.
The company is talking with the FDA to identify a patient population suitable enough for an upcoming study in patients with acute myelogenous leukemia (AML). Another go at the proverbial windmill or the final gasp of desperation from a company in trouble?
Given the shifting FDA standards, its unclear if Hemopure will ever get approved. Fake blood products were criticized in an article in JAMA back in April. Although, it should be noted that the “study” was co-authored by Public Citizen (and the normal conflicts of interest that come along with their involvement). The JAMA/Public Citizen “study” criticized the FDA for even allowing the products to be tested in people.
I first became acquainted with Biopure in 2000 or 2001 when I received a call from a broker at Salomon Smith Barney hyping the stock as the world’s greatest healthcare investment. The stock was trading near a $100 at the time. It’s currently trading at $0.50.
Biopure President and CEO Zafiris G Zafirelis (yes, that’s really his name) says: “We are very excited at the possibility of initiating a new clinical trial with Hemopure in the U.S.” Too bad shareholders don’t share his enthusiasm.
The company is talking with the FDA to identify a patient population suitable enough for an upcoming study in patients with acute myelogenous leukemia (AML). Another go at the proverbial windmill or the final gasp of desperation from a company in trouble?
Given the shifting FDA standards, its unclear if Hemopure will ever get approved. Fake blood products were criticized in an article in JAMA back in April. Although, it should be noted that the “study” was co-authored by Public Citizen (and the normal conflicts of interest that come along with their involvement). The JAMA/Public Citizen “study” criticized the FDA for even allowing the products to be tested in people.
I first became acquainted with Biopure in 2000 or 2001 when I received a call from a broker at Salomon Smith Barney hyping the stock as the world’s greatest healthcare investment. The stock was trading near a $100 at the time. It’s currently trading at $0.50.
Biopure President and CEO Zafiris G Zafirelis (yes, that’s really his name) says: “We are very excited at the possibility of initiating a new clinical trial with Hemopure in the U.S.” Too bad shareholders don’t share his enthusiasm.
Sunday, July 6, 2008
Global Biotech Sales Slow
Biotechnology products have been the saving grace of the pharmaceutical industry for the last few years. As the industry has found itself in an innovation draught, biotech could be counted on to deliver novel new products. While still the case, it is becoming less so.
A few weeks back, IMS Health released its global biotechnology report. IMS noted that biotech sales were $75 billion in 2007, up 12.5% from 2006. BUT, this was the lowest level of sales growth in over a decade. Call it slowing. Call it a plateau. Call it the first cracks in the great biotech façade.
IMS agrees. “After 20 years of what some would call a ‘charmed life,’ biotech is now facing a new reality,” said IMS’ Murray Aitken. “Loss of exclusivity and competition from biosimilars, crowded therapy areas with weaker sales growth, payers showing more reluctance to fund innovative drugs without compelling value propositions, and safety concerns for some therapies will all contribute to a more moderate growth environment through 2012. Yet, we expect the biotech sector to remain one of the most robust segments of the marketplace with a continued strong flow of innovative products to the market.”
Against the backdrop of slowing biotech sales, a number of individuals are clamoring for imitation biotech products (without FDA oversight). Most recently, Dr. Geoffrey Allan, CEO of Insmed (a company trying to jump on the follow-on protein bandwagon), published an article in the Richmond Times-Dispatch calling for a regulatory pathway for imitation biologics. While I support the introduction of follow-on biological products, the complexity of the molecules requires proper oversight…AND FDA trials to ensure that the follow-on molecules are as safe and effective of the originals. There should be no AB rating for imitation biological products given the complexity of molecules.
This issue will continue to play out over the next few years, but will only put further downward pressure on biotech sales.
A few weeks back, IMS Health released its global biotechnology report. IMS noted that biotech sales were $75 billion in 2007, up 12.5% from 2006. BUT, this was the lowest level of sales growth in over a decade. Call it slowing. Call it a plateau. Call it the first cracks in the great biotech façade.
IMS agrees. “After 20 years of what some would call a ‘charmed life,’ biotech is now facing a new reality,” said IMS’ Murray Aitken. “Loss of exclusivity and competition from biosimilars, crowded therapy areas with weaker sales growth, payers showing more reluctance to fund innovative drugs without compelling value propositions, and safety concerns for some therapies will all contribute to a more moderate growth environment through 2012. Yet, we expect the biotech sector to remain one of the most robust segments of the marketplace with a continued strong flow of innovative products to the market.”
Against the backdrop of slowing biotech sales, a number of individuals are clamoring for imitation biotech products (without FDA oversight). Most recently, Dr. Geoffrey Allan, CEO of Insmed (a company trying to jump on the follow-on protein bandwagon), published an article in the Richmond Times-Dispatch calling for a regulatory pathway for imitation biologics. While I support the introduction of follow-on biological products, the complexity of the molecules requires proper oversight…AND FDA trials to ensure that the follow-on molecules are as safe and effective of the originals. There should be no AB rating for imitation biological products given the complexity of molecules.
This issue will continue to play out over the next few years, but will only put further downward pressure on biotech sales.
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