Latest Drugwonks' Blog
According to incoming PhRMA Chairman Robert Hugin (chairman and CEO of Celgene), the advocacy group’s agenda in the coming year will target policies that “most directly affect innovation and patient access to medicines.”
Bravo.
Starting with Medicare, PhRMA will focus the conversation on why policies that seek to control costs by targeting drug spending will hurt patients. Hugin: “We have to have a good defense; we have to play this part of the game.”
In short, it falls to PhRMA to lead the fight for “sustainable innovation.”
Hugin highlights two main areas of concern related to Medicare. First, he said. “We have to protect Medicare Part D. It is the role model for market-based solutions.” Next he pointed to an increasing concern in industry with retaining adequate reimbursement for drugs provided under Medicare Part B (generall administered by physicians). The growth in very high-priced specialty drugs, such as targeted cancer therapies, is contributing to a new focus among payers on containing Part B drug costs.
Hugin: “We have to defend Part B. We have to ensure that reimbursement rates don’t change so significantly that access to patients for those types of medicines, physician-administered, are restricted, and [that] leads patients back to hospitals and higher [overall medical] costs.”
Among the other advocacy priorities, Hugin points to the need to “ensure the 340B program is administered effectively and appropriately.”
Amen.
According to Hugin, PhRMA will also focus on making sure the 12-year marketing exclusivity available to biologics under the law for biosimilars “is maintained, not just in this country, but in all the trade agreements that our country negotiates.” He also said that industry must “assertively defend intellectual property all across the globe.”
As per state exchanges and other codicils of the Affordable Care Act, Hugin stressed that, “We have to make sure that we support initiatives that … do not restrict access to important innovative medicines for patients all across this country.” And he vowed to “continue the fight” to repeal the Independent Payment Advisory Board, which was established by the ACA.
The biopharmaceutical industry, per Chairman Bob, must continue to support FDA and ensure “proper funding” of drug review programs “so that we have a 21st century regulatory science system that allows us, in the most cost-effective and rapid way, to bring new therapies to patients.” He commented that the trade association’s experience in negotiating the most recent prescription drug user fee act reauthorization bill, which was enacted last year with bipartisan support, was a “remarkably” positive one.
Nobody said it was going to be easy.
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.
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.
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.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.
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.
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.
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.
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.
Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.
