Adding FDA process to "the product is the process"

04/26/2013 10:08 AM |

When it comes to biologics, "the product is the process." Since the finished product cannot be fully characterized in the laboratory, manufacturers must ensure product consistency, quality, and purity by ensuring that the manufacturing process remains substantially the same over time.

As we move (albeit cautiously) into the era of biosimilars, one of the hoped-for advances is in manufacturing. Saying that such technologies are complicated is an understatement.

To achieve real success towards “better, faster, cheaper,” it is in the best interests of the public health for process mavens to work closely with the FDA to determine how new technologies can be expeditiously incorporated into biologics manufacturing standards.

Perhaps its time for the time for the FDA to create an advisory committee on biologics manufacturing standards and practices.

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The Interchangability Blues

04/25/2013 08:20 AM |

From today’s edition of the South Florida Sun Sentinel

Low costs medicines could jeopardize patient health

In Florida's House and Senate, lawmakers are currently working on legislation that would enable patients to purchase lower-cost alternatives to some of today's most-advanced medicines.

Unfortunately, a recent amendment to the legislation undermines the physican-patient relationship. It's critical for lawmakers to revert to their original proposal.

The legislation under consideration deals with a new class of medicines known as "biologics."

Unlike conventional drugs, which are made using basic chemical reactions, biologics are actually grown using living organisms. So they're much more complex. Consequently, when the patent on a biologic expires, competitors aren't able to make exact copies. But they can come close — so imitation biologics are called "biosimilars" instead of "generics."

Under federal law, the Food and Drug Administration will soon begin approving biosimilars. But the agency doesn't plan to issue any product-specific guidance to physicians or pharmacists prior to approving these drugs. And, it's not within the FDA's jurisdiction to tell states how to address the substitution of interchangeable biosimilars at the pharmacy — that responsibility falls to the state.

When Florida lawmakers in both chambers started work on their bills, they were model pieces of legislation — striking a balance between ensuring patient safety, and creating open access for more affordable new treatments.

The original bills stipulated Florida pharmacists would only be allowed to substitute a biosimilar for its brand counterpart if the FDA had certified the medicine as interchangeable with the innovator biologic.

The human body is complicated, of course, so it's possible that some biosimilars — even those deemed interchangeable by the FDA — will not work properly for certain patients, and because of the interaction of these treatments with a patient's immune system serious consequences can result.

The original legislation also required pharmacists to notify patients if a substitution had been made. And, because adverse reactions may not manifest themselves immediately, the bill also asked pharmacists to maintain dispensing records for four years. In the event that a biologic or biosimilar does not provide the intended treatment outcome, such records will prove vital.

Finally, and most importantly, the bill required pharmacists to notify prescribing physicians within ten days if a substitution had been made. It's important to underscore that this notification is required after the patient has already received the biosimilar.

These are all commonsense ssafeguards. They ensure that patients can access these less expensive new modifications safely.

But over the past week, House and Senate lawmakers have stripped the physician notification  from their bill. This doesn't make sense — it ignores the most fundamental aspect of protecting the patient by cutting doctors out of the loop.

This change undermines patient safety. Biologics are incredibly complex — on average, they contain 1,000 times the number of atoms found in conventional chemical drugs. Doctors, especially those treating patients with multiple chronic or autoimmune conditions, need to know when their patients walk away from the pharmacy counter with a different medicine than the one they prescribed.

This change also undercuts physician autonomy and ignores the importance of transparency. In order to effectively treat their patients and protect against unintended health effects, doctors have the right to know if a substitution is made.

In both the House and the Senate, the earlier draft of the bill puts patients first. As lawmakers finalize this measure, it's critical that they fulfill their responsibility to keep patients at the cent of this debate, and to make sure that the legislation passes with all protections intact.

Peter J. Pitts, a former FDA Associate Commissioner, is the president of the Center for Medicine in the Public Interest.

 

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FDA slams EWG

04/23/2013 10:17 PM |

FDA Cautions in Interpretation of Antimicrobial Resistance Data

Recently, the Environmental Working Group issued a report of its interpretation of the 2011 Retail Meat Annual Report of the National Antimicrobial Resistance Monitoring System (NARMS). While FDA is always concerned when we see antimicrobial resistance, we believe the EWG report oversimplifies the NARMS data and provides misleading conclusions. We do not believe that EWG fully considered important factors that put these results in context, including:

• whether the bacterium is a foodborne pathogen. The report highlights resistance to Enterococcus, but this is not considered a foodborne pathogen. Instead, we include it because its behavior is helpful in understanding how resistance occurs.
• which drug(s) the bacterium is naturally resistant to. For example, most Enterococcus faecalis is naturally resistant to the antibiotic class of lincosamides. Because we know and expect to see this resistance, we are not as concerned with resistance in this species the way we would be with resistance in true pathogens like Salmonella and Campylobacter.
• why NARMS includes certain drugs in its testing design. We include some antibiotics for epidemiology purposes-- to track the spread of certain bacteria or certain genes. But resistance to these antibiotics doesn’t reflect a danger to public health.
• whether the antibiotics that are commonly used to treat patients are still effective. NARMS data indicates that first-line treatments for all four bacteria that we track (Salmonella, Enterococcus, Escherichia coli and Campylobacter) are still effective.
• what the 2011 data indicate relative to similar data reported for prior years.

Additionally, we believe that it is inaccurate and alarmist to define bacteria resistant to one, or even a few, antimicrobials as “superbugs” if these same bacteria are still treatable by other commonly used antibiotics. This is especially misleading when speaking of bacteria that do not cause foodborne disease and have natural resistances, such as Enterococcus.

When taking such factors into account, FDA believes the notable findings in the 2011 NARMS Report include:

• In the critically important class of antimicrobials, the 2011 data showed no fluoroquinolone resistance in Salmonella from any source. This is the drug of choice for treating adults with Salmonella.
• Trimethoprim-sulfonamide is another drug used to treat Salmonella infections and resistance remains low (0% to 3.7%).
• Fluoroquinolone resistance in Campylobacter has stopped increasing and remained essentially unchanged since the FDA withdrew the use of this drug class in poultry in 2005.
• Macrolide antibiotic resistance in retail chicken isolates remains low, with 2011 results at 0.5% of Campylobacter jejuni and 4.3% of Campylobacter coli. The macrolide antibiotic erythromycin is the drug of choice for treating Campylobacter infections.
• Multidrug resistance is rare in Campylobacter. Only nine out of 634 Campylobacter isolates from poultry were resistant to 3 or more antimicrobial classes in 2011. However, gentamicin resistance in Campylobacter coli markedly increased from 0.7% in 2007 (when it first appeared in the NARMS retail meat report) to 18.1% in 2011. Gentamicin has been suggested as a possible second-line therapy for Campylobacter infections, although it is not commonly used.
• Resistance to third-generation cephalosporins, which are used to treat salmonellosis, has increased in Salmonella from chicken (10 to 33.5%) and turkey (8.1 to 22.4%) meats when comparing 2002 and 2011 percentages. FDA noted this development in previous years and has already taken action by prohibiting certain extra-label uses of cephalosporins in cows, pigs, chickens and turkeys, and is continuing to closely monitor resistance to these drugs.

Antimicrobial resistance is a serious and challenging issue. It is critically important that we continue our efforts to minimize antimicrobial resistance, including promoting appropriate and judicious use of antimicrobials in both humans and animals.

Based on a thorough review of the available scientific information, FDA has created a strategy for the judicious use of medically important antimicrobials in food-producing animals that states their use should be limited to situations where the drugs are necessary for ensuring animal health, and done so under veterinary guidance. It is the non-judicious use – for growth promotion and feed efficiency – that is of particular concern to FDA. This collaborative strategy is intended to provide the quickest way to achieve the greatest degree of public health protection, but it does not prevent FDA from initiating regulatory action in the future, if the agency finds it necessary. FDA welcomes all contributions in helping to understand and address the challenge of antibiotic resistance. However, it is very important to look at the NARMS data in the proper context, with a good understanding of the microbiology, epidemiology and genetics of antibiotic-resistant foodborne pathogens and their clinical management.   Read More & Comment...

Jindal opposes Medicaid expansion in Louisiana

04/23/2013 04:36 PM |

Louisiana Governor Bobby Jindal on why he opposes the expansion of Medicaid in his state:

This week, the Louisiana Legislature will begin debating legislation that would force Louisiana to expand Medicaid as part of President Obama's health care law. It's a bad move for Louisiana taxpayers. Here are seven reasons why we shouldn't expand Medicaid.

1. The expansion of Medicaid will move up to 171,000 Louisianians off of private insurance and stop another 77,000 people from going into private insurance. Combined, that would force about 248,000 people out of private coverage and put them into the Medicaid program. The actual uninsured population that should be focused on is about 214,000 people. Instead, President Obama's healthcare law would actually add double that number—over 450,000 people—to the Medicaid rolls.

2. President Obama's Medicaid expansion could cost taxpayers in Louisiana $1.7 billion over the first 10 years of implementation, and the cost will continue to rise. Additionally, the percentage of state funds spent on Medicaid has nearly doubled over the past 16 years and expanding the program could further threaten funding for higher education, transportation, and other critical services.

3. By expanding President Obama's healthcare law, 41 percent of Louisiana's population would be dumped into Medicaid. Soon there will be more people riding in the cart than people pulling the cart. The President is gradually turning the world's greatest health care system into the world's largest welfare system. The left has been very clear—their end goal here is to make all healthcare in America government health care.

Read the full column here.


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Kim Kardashian: Health Care Policy Expert

04/22/2013 02:35 PM |

Kim Kardashian recently observed:  “People freak me out all the time with all of their advice. Sometimes I’d rather just go through it and experience it on my own.”

I'm with Kim.  And it goes double with the waste of money and time most health care policy 'analysis' really is.   

Take this recent report from the Bipartisan Policy Center :

"Authored by former Senate Majority Leaders Tom Daschle and Bill Frist, former Senate Budget Committee Chairman Pete Domenici, and former Congressional Budget Office Director Dr. Alice Rivlin, who co-chaired the effort, the report contains over 50 integrated recommendations aimed at improving the affordability of care for all Americans.

"The four of us came together to change the conversation around how to improve health care and constrain cost growth. What we learned is that, until better care is prioritized over more care, our nation will continue to face a problem with health-care costs. This report is the culmination of nearly a year of work, including stakeholder outreach, thorough research and substantive analytics to quantify the impact of our proposed policies," said the co-chairs in an op-ed in The Washington Post today."

It took four smart people a year (including stakeholder outreach!) and hundreds of thousands of dollars to figure that out?   

I've started following Kim on Twitter.   Her approach to health care policy is a lot more reliable than the recombination of policy platititudes and presumptions that characterize most health care policy analysis.  



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More ObamaCare ads on the way

04/22/2013 01:02 PM |

From John Fund at National Review:
 
Obama officials insist the ads won’t be political, but critics recall that just before the 2010 midterm election, HHS spent $3.2 million on “educational” TV ads praising Obamacare. The spots featured the late actor Andy Griffith, a favorite of seniors, who told his fellow retirees that “more good things are coming” from Medicare. But FactCheck, a nonpartisan project of the Annenberg Public Policy Center, noted that the ads made no mention of the dramatic cuts to 10 million Medicare Advantage recipients, who are likely to see their privately managed care scaled back. “The words in this ad ring hollow, and the promise that ‘benefits will remain the same’ is just as fictional as the town of Mayberry was when Griffith played the local sheriff,” FactCheck concluded in July 2010.
 
Read more here.



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At least they're not calling it "academic detailing"

04/19/2013 09:02 AM |

The White House has given the FDA approval to ask doctors about the marketing practices of drug companies. The FDA's survey project, which is expected to cost as much as $365,000 over two years, will question physicians, nurse practitioners and physician assistants on their opinions about how drugs are promoted to consumers and healthcare professionals.

Stay tuned.

  Read More & Comment...

Public Comment App-ens

04/18/2013 07:42 AM |

In the era of social media, FDA must reassess the meaning of "open public comment."  Read More & Comment...

Avoiding the Gray Twilight

04/17/2013 07:35 AM |

Far better it is to dare mighty things, to win glorious triumphs even though checkered by failure, than to rank with those poor spirits who neither enjoy nor suffer much because they live in the gray twilight that knows neither victory nor defeat. – Theodore Roosevelt

Gray twilight be damned!

According to Rick Pazdur, if all drugs cleared for accelerated approval succeed in their confirmatory studies, then the FDA is being overly conservative in its use of the expedited approval pathway.

At the American Association for Cancer Research annual meeting in Washington, D.C., the Office of Hematology and Oncology Products Director said that if none of the drugs receiving accelerated approval is ever withdrawn, then the agency is taking an overly conservative approach in its approval of products under the pathway. “If you are demonstrating the correct degree of regulatory flexibility, there are going to be successes and there are going to be failures … If there are no failures, you … are being over-regulatory and over-conservative.”

Dr. Pazdur made his remarks while moderating a panel discussion among former chairpersons of the agency’s Oncologic Drugs Advisory Committee. A portion of the two-hour discussion focused on the FDA’s actions to withdraw accelerated approval of Avastin’s metastatic breast cancer claim -- and the lasting impact of that regulatory action on the accelerated approval pathway.

Pazdur: “If you take a look at the resources that went into that public hearing for Avastin, it would be impossible for the FDA to do that on a repeated basis,” he said. “I would just guesstimate that millions of dollars in resources, FTEs etc., lawyers, trying to do that hearing in a coherent fashion were spent, and probably even a greater amount by the company.”

Attention Policy Makers: Regulatory creativity, and innovation costs money.

 Pazdur: “I want to put forth a general principle here. If … the agency is using accelerated approval appropriately, there will be drugs that will have to come off the market,” he said. Accelerated approval may be granted based on a surrogate endpoint that is reasonably likely to predict clinical benefit, he noted. “That doesn’t mean that it’s a definitive demonstration.”

“You have to have a balance of drugs that make it and drugs that don’t if you are really going to be demonstrating the correct degree of regulatory flexibility. If all the drugs make it basically, why call it accelerated approval?

Precisely.  

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Biopharma Beats Obama (tax rate)

04/16/2013 07:21 AM |

According to a new report from PhRMA, the biopharmaceutical industry is the U.S.’ most research-intensive industry, dedicating 20.7% of domestic sales revenues to R&D investments in 2012.

That’s a higher percentage than the tax rate paid by President Obama!

For the year, the 31 PhRMA member companies invested an aggregate $48.5 billion in research and development. That total is down slightly from $48.6 billion in 2011 and a bit further from the record total of $50.7 billion tallied in 2010.

It is important to note that large bio/pharma companies such as Roche and Allergan are outside the scope of this report since they are not part of PhRMA so the R&D numbers would have been greater than what was reported.

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Promises to keep. Drugs to develop and the price is steep.

04/15/2013 09:18 AM |

“We must keep the promises we’ve already made.”

                        -- President Obama on Medicare

Like 12 years of data exclusivity for biologics?

The President’s budget has trotted out a deeply misguided healthcare idea. The President has his allies want to loosen "intellectual property" protection for an advanced class of pharmaceuticals called "biologics."

This is a mistake. Including this plan in any federal budget deal would inevitably undermine drug innovation, compromise care for millions of American patients, and -- ironically -- drive up long-term healthcare costs.

Unlike traditional chemical drugs, biologics are derived from living organisms. This makes them incredibly complex -- and uniquely effective. Biologics are one of the most promising modern healthcare technologies. Drug firms have already created breakthrough biologic treatments for some of the country's most prominent diseases, including HIV/AIDS, Alzheimer's and various forms of cancer.

A report from the research firm Credit Agricole predicts that six of the top twenty best-selling drugs next year will be biologics. Within five years, it's estimated biologics will comprise roughly half of the top 100 bestselling drugs in the country.

There are knock-off equivalents to biologics. They're called "biosimilars" or "follow-on biologics." However, unlike, say, that aspirin in your bathroom cabinet, a biologic can't be perfectly replicated. It's just too complex. A "follow-on" biologic will have some differences from the original.

It is possible to create a version of an innovator biologic that's close enough to the original to have basically the same therapeutic effects.  Given this fact, traditional patent protections aren't sufficient to foster innovation.

This is why biologics need an additional layer of intellectual property protection. And that's where data exclusivity comes in. This statute prevents outside firms from accessing the research data behind a new biologic for a preset period of time. This way, the original inventor has a limited market monopoly, during which they can try to recoup their development costs in sales. The 12 years of exclusivity granted under the Affordable Care Act, while still less than the 14 allowed in Europe, is a good compromise.

Mounds of research shows that data exclusivity should be set at around 12 years to give the average biologic a chance to at least break even.  The White House wants to scale back that period.

A recent deficit deal crafted by the administration included a provision that would scale back the period of data exclusivity granted to biologics from 12 to 7 years. The idea is that allowing lower priced biosimilars to flow into the market sooner will drive down costs for public insurance programs and generate major savings for the federal treasury.

While shortening biologic data exclusivity could generate some short-term financial gains, it will ultimately reduce the rate of medical innovation and deprive American patients of life-saving new treatments.

The brute reality is that if data exclusivity drops to seven years, many biologic innovators won't have enough time to make back their original investment before biosimilars flood the market and siphon away their profits.

After all, creating a biologic is an incredibly expensive, time-consuming, and risky endeavor. The average biologic costs well over a billion dollars to develop. For every 10,000 compounds tested in the lab, only one will wind up getting federal approval and making it to market. And simply making it to market is no guarantee of profit. Only about three out of every ten new pharmaceutical medicines will ever recoup back its development costs in sales.

If the government reduces the exclusivity window for biologics, many drug firms will actually end up losing money on that massive investment. That leaves less capital to pour into new drug research operations. And outside investors will be less willing to underwrite new research initiatives given that their chance of even breaking even on a new treatment has dropped significantly.

Ultimately, that means fewer new drugs for American patients.

The Obama administration and its allies need to drop this push to scale back data exclusivity protections for biologic drugs. These treatments have proven to be highly effective at improving patient health and saving lives. Diluting the intellectual property rights protecting biologics will slow down the rate of innovation and choke off the flow of new treatments.

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Robert Hugin Tells PhRMA: No Apologies

04/12/2013 01:05 PM |

Here's the crux of Celgene CEO Robert Hugin's first speech as chair of PhRMA:

"We should never be defensive; we should never temper our passion for the positive impact that we can create together for patients, for our economy and for our country.  And we should take this optimistic vision of the future and our passion for innovation to policymakers in this country and around the world. "

When's the last time a drug or biotech trade group leader actually stood up for commercialization instead of apologizing for it or stated that commercialization of medical science is the source of most of the world's progress in the past half century?  Hugin just didn't restate PhRMA's agenda, he made a case for pushing it without pride.  

Celgene's corporate campus is bracketed with banners that proclaim: "Discovered Here. Developed Here. Commercialized Here."   It sounds like Hugin is carrying that message into his tenure as PhRMA chair. 


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The Invisible Sequester

04/12/2013 09:09 AM |

Remember the game show Password? The program’s slogan was “It’s not what you say -- it's what you don't say.”

And so it is with the sequester at the FDA. It’s not what the agency is doing – it’s what they’re not doing.

According to an article in the April edition of Nature Biotechnology:

The budget sequester is “not the end of the world, but it’s not good for FDA,” says Peter Pitts, president of the Center for Medicine in the Public Interest in New York. For example, PDUFA dates may need recalibrating. US Department of Health and Human Services (HHS) secretary Kathleen Sebelius has warned that FDA cutbacks will heighten food safety risks from fewer inspections, but Pitts points to longer-term strategic effects arising from the sequester. “Anything having to do with policy development, such as dealing with biosimilar drugs, will grind to a halt,” he says. “The sequester will delay regulatory innovation by pushing things that are important but not life-threatening off the agenda.”

It’s the invisible hand of innovation postponed that is the most pernicious aspect of the White Oaks sequester.

The complete Nature Biotechnology article can be found here.

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The Committments: Part I

04/11/2013 10:32 AM |

Here's the Federal Register notice announcing the 12 disease areas that have been selected by FDA for the PDUFA V patient-focused drug development meetings in FY2013-2015.

SUMMARY: The Food and Drug Administration (FDA) is announcing the selection of disease areas to be addressed during the first 3 years of Patient-Focused Drug Development. This 5-year initiative is being conducted to fulfill FDA’s performance commitments made as part of the fifth authorization of the Prescription Drug User Fee Act (PDUFA V). It provides a more systematic approach for the Agency to obtain patients’ input on specific disease areas, including their perspectives on their condition, its impact on daily life, and available therapies. FDA selected these disease areas based on a set of selection criteria, the perspectives of the reviewing divisions at FDA, and the public input received on a preliminary set of disease areas published in the Federal Register on September 24, 2012.

FDA has selected the following diseases to be addressed in FY 2013–2015:

* Alpha-1 antitrypsin deficiency;

* breast cancer;

* chronic Chagas disease;

* female sexual dysfunction;

* fibromyalgia;

* hemophilia A, hemophilia B, von Willebrand disease, and other heritable bleeding disorders;

* HIV;

* idiopathic pulmonary fibrosis;

* irritable bowel syndrome, gastroparesis, and gastroesophageal reflux disease with persistent regurgitation symptoms on protonpump inhibitors;

* lung cancer;

*  myalgic encephalomyelitis/chronic fatigue syndrome;

* narcolepsy;

* neurological manifestations of inborn errors of metabolism;

* Parkinson’s disease and Huntington’s disease;

*  pulmonary arterial hypertension;

* sickle cell disease

Discuss.
 

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The Tavenner Two-Step

04/10/2013 08:24 AM |

From the pages of Medical Marketing & Media ...

For Obama's head-less CMS, third time's the charm

Matthew Arnold

Marilyn Tavenner told Senators if confirmed as director of the Centers for Medicare and Medicaid Services, she will “operate CMS like a business” and keep an open door policy to “listen to all the groups accountable” to the programs.

Tavenner, an ICU nurse-turned-hospital exec-turned-Virginia health secretary, is setting a very different tone from President Obama's last nominee for the post, Don Berwick, whose favorable comments about the UK's National Health Service raised industry hackles. She's before the Senate today, in hearings to make her job official at a pivotal time for the program.

While her confirmation has been on ice for more than two years, she comes to Capitol Hill with bipartisan support – Republican majority whip Eric Cantor, a fellow Virginian who has known Tavenner since her days running a hospital in her district, is a fan. She's received support from all the major industry stakeholders, which are impatient for the programs to have permanent leadership.

“At this stage in the healthcare reform conversation, it's important to have a CMS administrator who will ensure that patient care always comes first and that cost containment isn't wedded to failed foreign models of rationing,” said Peter Pitts of the Center for Medicine in the Public Interest. “Ms. Tavenner has demonstrated both the ability to focus on the job at hand and avoid doctrinaire political debate.”

“It's time for Congress to stop playing politics with major cabinet appointments,” said Coalition for Healthcare Communication executive director John Kamp. “The president won the election and should be given the respect to appoint his people.”

For political reasons, it's been a decade since CMS had a permanent head, and as the Washington Post notes, the senior President Bush's Medicare director Tom Scully has mused that “Mother Theresa or Gandhi couldn't even get confirmed,” so contentious have the politics of the programs become in the age of the Affordable Care Act. An earlier nomination of Tavenner went nowhere.

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Fallout Shelter

04/09/2013 05:37 AM |

Best reportage anywhere on the recent Plan B decision. Not surprisingly, it’s by Steve Usdin of BioCentury. The article is titled, “Plan B’s Fallout.”

Two selected paragraphs to share:

Peter Pitts, who was associate FDA commissioner during the Bush administration when the Plan B storm first broke, also bemoaned the interference with a science-based decision. “Unfortunately, it’s on the prickly topic of reproduction rights,” he told BioCentury This Week. “But at the end of the day, the Secretary overruling the FDA on a scientific issue brings to bear many negative, unintended consequences.”

Ironically, according to Pitts, Korman’s ruling actually could undermine FDA’s ability to make decisions based on its scientific judgments. Sebelius’ intervention raised the specter of companies appealing FDA decisions to the HHS secretary, and Korman’s ruling suggests they might seek to overturn regulatory decisions in the courts, he said. “The court told the FDA to make a certain regulatory decision and that sets a dangerous precedent,” according to Pitts. “I agree with the decision, but I would feel better if he’d said it was based on FDA’s decision that was overturned by the secretary.”

The entire article can be found here – and it’s worth a read.

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The Big Fight

04/08/2013 08:06 AM |

On Saturday I was a panelist on the highly rated Indian public affairs television program, “The Big Fight.” The topic, the Indian Supreme Court’s ruling against Novartis and Gleevec.

My fellow panelists included an attorney from Ranbaxy, a representative from Novartis, an activist from Doctor’s Without Borders (MSF), a financial journalist, and a representative of the Indian pharmaceutical industry.

And it was, indeed, a big fight.

Expertly moderated by Vikram Chandra (one of India’s most respected journalists), the topics ranged from innovation to access to domestic industrial policy.

Mr. Chandra asked me if big multinational pharmaceutical companies made too much money. My response was that I didn’t know what “too much” meant – but that it was a good thing that most company profits are reinvested in R&D.

What I didn’t have time to say was that, as far as “excess profit” goes, that question is a lot more relevant to Indian drug manufacturers. Their profits last year were much higher than any innovator company. At Dr. Reddy’s net profits are up 88%. At Lupin profits are up 67%. And, at Sun Pharmaceuticals profit after taxes for the last year was 39%.

And while we’re in the pot calling the kettle black department, consider the claim by MSF India that access is the key issue. Really?

Less than 10% of India's CVD patients get even the most common medicines like diuretics and statins. Yet there are 10,500 licensed Indian drug manufacturers producing hundreds of generic anti-hypertensives and other CVD products on the market in India – very few of which reach India’s 45+ million diagnosed CVD patients.

The complete “Big Fight” can be found here.

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Right Decision. Wrong Venue.

04/05/2013 10:53 AM |

Judge Edward Korman of the U.S. District Court, Eastern District of New York (Brooklyn) has ordered FDA to make Plan B available OTC without restrictions.

Perhaps a better way to say that is that the court has upheld the FDA's decision that was countermanded by Secretary Sebelius.

No matter how you look at it, it's dangerous for outside bodies (be they in the Humphrey Buidling or judicial robes) to tell FDA how to handle decisions that must (must!) be based on sound science. And only sound science.  Read More & Comment...

Cowboys and Indians

04/05/2013 07:19 AM |

According to a report in BioCentury, Senator Chuck Grassley (R, IA) has asked HHS's Health Resources and Services Administration for information on the agency's oversight of the 340B discount program, which requires manufacturers to give deep discounts on outpatient drugs to hospitals and clinics that provide healthcare to low income and other special populations.

In a letter to Administrator Mary Wakefield, Grassley requested information about whether and what type of data HRSA collects on how much revenue hospitals receive by participating in 340B, as well as how hospitals reinvest this revenue. He noted that data from three North Carolina hospitals show the hospitals are "reaping sizeable 340B discounts on drugs and then turning around and upselling them to fully insured patients" covered by Medicare, Medicaid or private insurance, which he said is "contrary to the purpose of the 340B program." Grassley asked for a response from HRSA by April 22. HRSA said it will respond to Grassley's letter.

Grassley's request comes less than two months after patient and industry groups released a report calling for a Congressional examination of the 340B program, and several months after a group of Congressional Republicans that included Grassley asked for details on HRSA's audits of the eligibility of healthcare entities for the program.

In a response to Grassley's letter, the trade group Safety Net Hospitals for Pharmaceutical Access (SNHPA) said both HRSA and HHS "have specifically acknowledged that Congress intended for hospitals to charge above the 340B acquisition cost" for patients covered by Medicare or private insurance. The group also said federal reports "clearly demonstrate" that hospitals are using revenue from the 340B program to benefit "uninsured, underinsured or otherwise vulnerable" patients.

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India's Patent Nonsense

04/04/2013 09:28 AM |

Gleevec case as reported by NDTV (New Delhi TV). Television segment can be seen here.

Indian drugs will now face backlash, warn analysts in US after Novartis ruling

NDTV | Reported By: Namrata Brar

Has India's Novartis ruling just killed its own innovation dreams? Will India's generic manufacturers now get slammed in their overseas markets?

While India celebrates the Novartis ruling, the United States is condemning it. The USA provides nearly 50 per cent of the profits to big pharma and India's bold decision has sent alarm waves in the lobbyist circles.

The Supreme Court on Monday dismissed Swiss drug-maker Novartis AG's attempt to win patent protection for its cancer drug Glivec, a blow to Western pharmaceutical firms targeting India to drive sales and a victory for local makers of cheap generics.

The decision sets a benchmark for intellectual property cases in India, where many patented drugs are unaffordable for most of its 1.2 billion people, and does not bode well for foreign firms engaged in ongoing disputes in India, including Pfizer Inc and Roche Holding.

"In my opinion, the Supreme Court's decision was not a patent ruling but a domestic economic policy decision," said Peter Pitts, President and Co-Founder of the Center for Medicine in the Public Interest (CMPI) and a former associate commissioner at Food & Drug Administration. "I don't agree that companies will be forced to invest in India at the end of the day because India is too big a market to ignore. If the Supreme Court of India does not understand something as basic as a beta crystal reformulation, then what hope is there for any patent?"

"If the Government of India does not understand the importance of incremental innovation, there are pretty rocky days ahead for the international community and the (Indian) government," Mr Pitts added.

While the Indian pharma market will be among the world's top 10 pharma markets by 2015, topping $20 billion (Rs. 1,08,580 crore), many in the United States feel that its restrictive patent laws will impede its growth.

The Indian pharmaceuticals industry should not celebrate too soon. On the surface the ruling might be a win for generics but in the longer term, the Big Pharma could retaliate. The US is the biggest market for Indian generics -- India exports generic drugs worth $11 billion (Rs. 59,825 crore) -- and any setback will hit them hard; the ruling could lower the chances of Indian generics companies winning contracts in the US and elsewhere. The days of Ranbaxy's Lipitor exclusivity will not come easily again.

The even bigger fear is: will innovation flee from India?

Shibani Malhotra, Global Healthcare Analyst at RBC Capital Markets, said, "Foreign investment will certainly reconsider its options... foreign majors who were investing in key partnerships with domestic Indian players, like the Abbot-Piramal deal, might have a change of heart. The idea for the investment was to build infrastructure -- a bigger foothold to launch high value drugs which now will be a difficult proposition. More importantly, what happens to a Biocon when it comes out with a new innovation? It won't want to do business in India, it would rather go to the US. India is killing its own prospects."

"We are disappointed with the decision of the Supreme Court, and remain concerned about the environment for innovation and investment in India," Pfizer said in a statement issued to NDTV.

In the US  -- the heart of big pharma lobbying -- there is massive criticism of India's decision. Will companies like Novartis delay cutting edge drugs to the Indian market? May be. Will global pharma foreign direct investment in India rethink its path? May be.

One thing is certain -- the US pharma majors will not take this lying down. They say if India can be protect its generic drug makers, they too will protect their turf. This means Indian generics may be in for a tougher backlash in global markets.

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