Latest Drugwonks' Blog
As the February 4th FTC workshop on follow-on biologics approaches, here’s another VIP (Very Important Perspective) that the Commission has chosen not to bring to the public. Today’s VIP is a physician with experience prescribing and treating patients with biologics. Dr. Bert Petersen, a surgeon, is director of the Breast Surgery Clinic of St. Barnabas Hospital in New York City and an adjunct associate professor of surgery at New York University School of Medicine. Dr. Petersen is an advocate for the elimination of health disparities, particularly in terms of cancer and chronic diseases. Here are his thoughts on why the biologics naming issues matters for both him and his patients.
Q: What role do biologics play today in treating patients?
A: In my field, cancer – specifically breast cancer, we’ve seen great success in treatment for early and advanced stages with biologics. As we move toward more targeted therapies for chronic disease, they play an increasingly important role.
Q: Do you think there may be certain populations who are more at risk to an immunologic response from a biologic?
A: Yes. Any populations that may have a compromised immune system—specifically, many patients with chronic disease—can be impacted. These include at risk populations such as the elderly, immune deficient and chronic renal disease patients, etc. Additionally, at-risk populations tend to be patient populations that may lack quality insurance or access to healthcare. Furthermore, many of these chronic diseases disproportionately impact the poor. This makes access to biosimilars even more important for this population
Q: What value could biosimilars offer patients?
A: Two of the biggest reasons to look at biosimilars are cost and access. Can we offer the same effective treatment while controlling cost? My biggest concern is how we increase equal access to quality health care. We want to increase our reach in expanding healthcare, but it must be quality health care. Biosimilars offer a chance to meet the goals of affordable and quality treatment options.
Q: What is your view on the best approach FDA could take on biologics naming and how does distinguishable naming help keep our biologic supply safe?
A: Unlike any other field, medical decisions must be met with great scrutiny and thoughtfulness because any mistakes or missteps can be fatal. Patient safety should be the FDA’s overarching principal when it comes to approving biosimilars and any other drug.
In terms of distinguishable naming, I believe that biosimilars definitely should have different names, so you can determine if drugs are equal in their effectiveness. In my opinion, it’s unethical to treat patients with something pretending to be something else when it may or may not be. It’s also unsafe. I have a real problem with this as a practicing physician who treats patients with life threatening illnesses.
Q: Why is it important for patients and doctors to know what biologic is being, and has been put into, a patient’s body?
A: Much of how we practice is based on evidence-derived medicine. This is how we gather our evidence to know what is effective and what is not. Understanding which biologics patients have used will help us as we move toward the future to make any modifications that are found necessary.
Q: What impact would distinct naming have on trust in biosimilars?
A: I think if we could distinguish drugs, providers would have less hesitation in prescribing them. If providers are more educated and they have a clear pathway to report adverse effects—they would be more motivated to trust and prescribe biosimilars.
Thank you, BertWASHINGTON (AP) — It seems to be something of an occupational hazard for President Barack Obama: When he talks about his health care law, he's bound to hit a fact bump sooner or later.
OBAMA: "More than 9 million Americans have signed up for private health insurance or Medicaid coverage."
THE FACTS: That's not to say 9 million more Americans have gained insurance under the law.
The administration says about 6 million people have been determined to be eligible for Medicaid since Oct. 1 and an additional 3 million roughly have signed up for private health insurance through the new markets created by the health care law. That's where Obama's number of 9 million comes from. But it's unclear how many in the Medicaid group were already eligible for the program or renewing existing coverage.
Likewise, it's not known how many of those who signed up for private coverage were previously insured. A large survey released last week suggests the numbers of uninsured gaining coverage may be smaller. The Gallup-Healthways Well-Being Index found that the uninsured rate for U.S. adults dropped by 1.2 percentage points in January, to 16.1 percent. That would translate to roughly 2 million to 3 million newly insured people since the law's coverage expansion started Jan. 1.
OBAMA: "Because of this (health care) law, no American can ever again be dropped or denied coverage for a preexisting condition like asthma, back pain or cancer. No woman can ever be charged more just because she's a woman. And we did all this while adding years to Medicare's finances, keeping Medicare premiums flat, and lowering prescription costs for millions of seniors."
THE FACTS: He's right that insurers can no longer turn people down because of medical problems, and they can't charge higher premiums to women because of their sex. The law also lowered costs for seniors with high prescription drug bills. But Medicare's monthly premium for outpatient care has gone up in recent years.
Although the basic premium remained the same this year at $104.90, it increased by $5 a month in 2013, up from $99.90 in 2012. Obama's health care law also raised Medicare premiums for upper-income beneficiaries, and both the president and Republicans have proposed to expand that.
Finally, the degree to which the health care law improved Medicare finances is hotly debated. On paper, the program's giant trust fund for inpatient care gained more than a decade of solvency because of cuts to service providers required under the health law. But in practice those savings cannot simultaneously be used to expand coverage for the uninsured and shore up Medicare.
Although FDA is tasked with creating naming policy for biosimilars before they enter the U.S. market, FTC is trying to force its misguided view on the issue in the hopes of building advocates for non-unique names. During a workshop scheduled for February 4 will delve into the biosimilars naming issue, but somehow they forgot to include a number of VIPs (Very Important Perspectives). Amazingly, patient advocates are nowhere to be found on the agenda; also absent are physicians who prescribe biologics and health system pharmacists.
Because of FTC’s slight – presumably so they could through the workshop arrive at near consensus on the need for biosimilars to share the same name as the innovators to which they related, and in doing so muddy the central facts that distinguishable naming is the right approach for efficient adverse event reporting, patient safety and even promoting uptake of and competition among biosimilars.
Today’s VIP on the issue is that of the first person – the actual long-time and life-long biologics user. Donna Cryer is really a patient-plus though – in addition to using a mix of biologics and synthetic medicines for rheumatoid arthritis, inflammatory bowel disease, to preserve a transplanted liver she received nearly 20 years ago, and to deal with kidney issues that impair her body’s ability to make red blood cells, Donna is a Harvard-trained health policy lawyer, a patient representative on an FDA advisory committee and the first patient to serve as Chairman of the American Liver Foundation. Here’s Donna’s perspective on why the right naming policy for biosimilars and all biologics matters for her and the millions of other biologics users like her.
Q: What role do biologics play in treating patients?
A: Biologics play an incredibly important role in treating patients, like me, who have multiple autoimmune conditions. My life really depends on biologic medications. And for so many thousands of other patients, our health, our productivity, our ability to work and be with our families all are because we have access to biologic medications.
Q: What value could biosimilars offer to patients like yourself?
A: Biosimilars often offer lower cost options, so that can provide more access to medications for more patients.
Q: Why is it important for patients and doctors to know which biologic is being and has been put into a patient's body?
A: It is essential that doctors and patients know exactly which medication, particularly with biologics, they are prescribing and using. Being able to manage a disease based on the reactions of your immune system is really tricky. You want to make sure that you are not suppressing the immune system so much that you are open to every infection, every cold, as well as more serious conditions like tuberculosis. Knowing exactly which biologic medication you're taking is absolutely vital because if there is a side effect, an adverse event, or just a change in your condition and your body's response, you want to be able to track it back to exactly the drug that you were prescribed, exactly the drug that you took.
Q: Since biologics are more complex than normal, chemical prescription medicines, how does that alter the conversation and relationship you have with your doctor?
A: The doctor/patient relationship is based on trust. In fact, the patient relationship within the entire healthcare system is based on trust, and a high degree of confidence, that what we're being prescribed, what we rely on for our very lives, is safe and effective. We want to be able to know, and have confidence that our biosimilars and biologic medications are distinguishable, so that we can know what we're taking, how we're taking it, how it differs.
Q: From your view as a patient, what would be the best approach the FDA could take when creating a naming policy for biosimilars?
A: Well, the issue of biosimilars naming is really important, because unless FDA ensures that unique distinguishable names for biosimilars are given, patients and doctors really will be left without any recourse to track back and understand what medication might have caused their adverse event or their side effect. We want to be able to track back if there is an issue, a side effect, a serious adverse event, or just a change in our condition. We want to be able to know. We deserve the right to know what we have taken so that we can have recourse, if need be, about what has happened and what is happening to our bodies. As a patient, I'm not really sure why there is even an argument about having a distinguishable name for a biosimilar: it's such a simple solution to have a distinguishable name.
Thank you, Donna.
The Wall Street Journal reports:
NEW DELHI—Workers at a Ranbaxy Ltd. drug plant repeatedly fudged test results to make it appear that raw materials and active pharmaceutical ingredients met required standards when they didn't, according to a report by inspectors from the Food and Drug Administration.
FDA officials visited Ranbaxy's Toansa factory in the northwestern Indian state of Punjab early this month and said they discovered workers retesting "until acceptable results are obtained" and deleting evidence of failed tests.
The FDA inspectors also noted that analytical and microbiological laboratories at the plant were in "significant disrepair," with windows that couldn't close and a sample-preparation room with flies that were "too numerous to count."
In one lab, the FDA report said, inspectors "identified the presence of numerous sticky notes" that were found to "contain instructions for corrections to be made to the raw data" for testing. The inspectors also wrote that they had observed a worker in the quality-control lab backdating a log entry.
"We immediately questioned this analyst regarding the reason for backdating his record, who responded that he had only entered '2014,' despite our visual observation of him entering a signature and full date entry a few moments earlier," the report said.
On January 6th, CMS issued a proposed rule that would result in foundational changes to Medicare Part D and negatively impact America’s seniors, and other constituencies. Most disturbingly (if not surprisingly) it reveals the Administration’s authentic view of Part D by attempting an unprecedented level of government interference with what was intended to be a competitive, market-based proposition. Specifically, the proposed rule:
· Interprets the statutory non-interference provision for the first time since the MMA passed in 2003.
· Imposes new, non-statutory restrictions on sponsor contracts and plan bids, limiting sponsors to no more than two plans per region.
· Intervenes in private market contracting between Part D plans and network pharmacies.
· Further encourages the displacement of employer-provided coverage that the MMA intended to preserve.
· Introduces enormous uncertainty into the market for plan sponsors as they prepare for the 2015 bid cycle.
· Places new restrictions on access to medicines in classes of clinical concern, including mental health drugs and drugs to prevent organ transplant rejection.
Why this rule and why now? One explanation is that it shows the continuing cognitive dissonance of the administration (and career CMS staff) that anything driven by the free-market could possibly work –- and that seniors are not capable of making their own healthcare choices. And it doesn’t matter that both of these almost religious beliefs fly in the face of all facts and figures to the contrary.
This rule is designed to solve a problem that doesn’t exist – but which its authors believe should exist. The proposed rule creates a Bizarro Part D wherein the role of free-market forces and the imperative of citizen choice are replaced by the heavy hand of the infallible Uncle Sam, MD.
Think about it: This proposed rule would limit competitive bidding, limit patient choice, and stifle innovation in plan design. In short, it would gut the philosophical framework of Part D –- a framework that has consistently resulting in government spending coming in under budget with 90%+ user satisfaction.
All this and the proposed rule also revises long-standing prior agency policy on the “six protected classes” policy. Specifically targeted are medications for mental illness. The proposed rule revises long-standing prior agency policy that required Part D plans to include on their formularies “all or substantially all” drugs within six classes: anti-depressants, antipsychotics, anticonvulsants, antineoplastics, and immunosuppressants. This policy has been in effect since the inception of Part D, and has strong congressional support.
Why? Why fix something that isn’t broken? Maybe it’s all a “fix” of a different kind. Maybe this proposed rule is designed to ruin Part D so the argument can be made for direct government interference and, ultimately, a move to a single payer system.Remember, you’re not paranoid if they’re really out to get you.
And just wait until they start exporting biosimilars.
WASHINGTON (AP) -- U.S. health regulators said Thursday they are barring imported drugs from an overseas factory operated by Ranbaxy Laboratories, India's largest drugmaker, due to quality control violations.
The Food and Drug Administration ban effectively stops the company from shipping drugs and raw ingredients from its Toansa plant in the Punjab province. A Jan. 11 inspection by FDA staffers uncovered factory workers retesting drug ingredients that had failed quality testing, in an apparent effort to return positive results. Those practices and others found at the plant violate manufacturing standards for drugmakers that do business in the U.S.
"The FDA is committed to ensuring that the drugs American consumers receive - no matter where they are produced - meet quality standards and are safe and effective," said FDA compliance director Carol Bennett.
Ranbaxy did not immediately respond to requests for comment Thursday.
Ranbaxy will be required to hire an outside inspector to review the plant and certify that it is meeting U.S. quality standards before the ban can be lifted.
In September the FDA placed a similar hold on imports from Ranbaxy's Mohali facility. Both actions were taken under a 2012 legal settlement with the FDA, which subjects Ranbaxy to extra scrutiny and inspections to improve its drug production.
With annual revenue of more than $2 billion, Ranbaxy is the leading drugmaker in India's $26 billion generic pharmaceutical industry, but it has faced penalties from U.S. regulators for years.
In May, the company's American subsidiary agreed to pay $500 million in fines and penalties for selling adulterated drugs and lying to federal regulators, the largest financial penalty against a generic drug company for violations of the Federal Food, Drug and Cosmetic Act, which prohibits the sale of impure drugs.
Yesterday 28 Republican lawmakers from both the House and Senate (led by Senate HELP ranking member Lamar Alexander and House Energy and Commerce Chairman Fred Upton) sent a letter to the FDA voicing their concern over the agency’s proposed rule that would allow generic drug companies to change the safety information on the labels of their products. Their fear is that “equivalent products could temporarily” end up showing “different safety information” before “the FDA determines if the changes are warranted.”
Dr. Janet Woodcock, the F.D.A.’s head of drug evaluation and research, said the proposed change would create better parity between brand-name drug manufacturers and generic companies, which is especially important given that more than 80 percent of prescriptions in the United States are currently dispensed as generic drugs. “Now, with the generic industry having grown up, most people are taking generic drugs,” she said. “It’s really time to level the playing field.”
But, methinks, the 28 signatories have been pretty heavily lobbied, because there’s another issue here that’s not safety related.
The proposed rule would also pave the way for lawsuits from patients who could now claim that generic companies did not sufficiently warn them of a drug’s dangers. In 2011, the Supreme Court ruled that such lawsuits were not valid because generic companies were required to use the same label warnings as brand-name manufacturers and thus could not be blamed for failing to warn patients about the risks of taking their drugs.
It’s interesting to note that Senator Alexander has also been front and center in lobbying the FDA on the biosimilar INN issue. He does not believe in differentiation.
Why does his concern about safety and clarity apply only to small molecules? Hm.
For more on this issue, see “Generic Originals.”
Sometimes statements of the obvious are useful. Here’s one from Yale University’s Nicholas Downing, a third year medical student at Yale University School of Medicine and lead author of a new study, which examined nearly 200 new drug approvals between 2005 and 2012:
“Not all FDA approvals are created equally.”
According to the Washington Post, “Downing and his team found broad differences in the data it took to get a thumbs up from FDA. For instance, the agency required that many new drugs prove themselves in large, high-quality clinical trials. But about a third won approval on the basis of a single clinical trial, and many other trials involved small groups of patients and shorter durations. Only about 40 percent of approvals included trials in which the new drug was compared with existing drugs on the market.”
“There was a lack of uniformity in the level of evidence the FDA used,” Joseph Ross, assistant professor of internal medicine at Yale and a senior author of the study, said in announcing the findings.
Well, duh.
The Yale study, funded by the Pew Charitable Trusts and published Tuesday in JAMA, acknowledges that the FDA has valid reasons for its varied requirements.
“Such regulatory flexibility allows for a customized approach to approval,” it states, “including the ability to rapidly approve potentially effective therapies for life-threatening diseases, such as certain cancers, or those diseases for which there is no existing effective treatment, such as orphan diseases.”
Downing, the study’s lead author, said the analysis is not intended to suggest that the FDA should use a one-size-fits-all approval process or that it somehow has approved the wrong drugs. Rather, he said, it was meant to educate people who assume that all new drugs have cleared the same amount of safety testing before ending up on the market.
“It’s very understandable that regulators have a flexible standard for approval, but patients and doctors need to be aware the standard is flexible,” he said. “It’s important for doctors and patients to have a discussion about how much we know about the potential benefits or risks of taking a drug before they take it . . . [and] it underscores the need to continue to study these drugs after approval.”
Yep. Not new – but worth repeating.
Missing from the Yale study is the relevant fact that, per PDUFA V, the FDA is designing a five-item grid as a management tool to explain its risk-benefit decisions in a more concise format. The model that it has created as a working template confirms a truism about its drug approval tendencies that industry has suspected for years: the baseline for FDA approval is a high rating of the severity of the disease being treated and the medical need for the product.
The agency is developing a grid of the five basic factors that need to be addressed in any decision on the commercial availability of a drug. The top two are the seriousness of the condition addressed and the need for a new treatment of the condition. Then comes the traditional heart of the NDA package: analyses of clinical data on the benefits of the drug and the risks associated with its use.
The fifth fundamental factor is explicitly the level of risk management associated with the product. The FDA is going to take it into consideration in every decision; sponsors who ignore or underplay the identification of who should use the product and who might use it will have a gap in their filings.
The grid proposal does not call for a fixed mathematical formula behind each approval. The agency has not tried to reduce the judgments in an approval decision to a rigid calculation.
Judgment? You mean FDA decisions aren’t black and white?
In the words of John Jenkins, director of the Office of New Drugs at the Center for Drug Evaluation and Research, disagreement “happens a lot in the decisions that we have to make. Very few of the decisions that we make on drugs are easy. Very few of the drugs we see have a dramatic overwhelming benefit with relatively no risk. We see that most drugs have marginal to moderate benefits on a population basis and they have general safety but they have the risks of serious toxicities at some low levels." In other words, every decision is very complex.
The unspoken danger is that regulators love ambiguity because ambiguity is power. That’s different than regulatory flexibility – which is a good thing. But it’s a fine line and the distinction is often in the eyes of the beholder. But it is certainly a distinction with a difference.
Some snippets from the National Council on Patient Information and Education’s report, Accelerating Progress in Prescription Medicine Adherence: The Adherence Action Agenda: A National Action Plan to Address America’s “Other Drug Problem”
At the same time that medical science has transformed HIV and many cancers into treatable conditions and significantly reduced the burden of chronic diseases like diabetes, many Americans are not benefiting from these treatment advances due to the persistent problem of poor prescription medicine adherence—a pervasive problem the leads to unnecessary disease progression, disease complications, a lower quality of life, preventable deaths, avoidable medical spending and lost work productivity.
Based on the latest estimates, half of the estimated 187 million Americans who take one or more prescription medicines—or up to 93.5 million patients—do not take these drugs as prescribed. In fact, studies show that 20% to 30% of prescriptions are never filled by patients, while 50%–60% of medications to treat chronic disease are not taken as prescribed. In terms of the toll in morbidity and mortality, lack of medication adherence is associated with poorer health outcomes, resulting in approximately 125,000 preventable deaths a year and many as 40% of nursing home admissions in people with type 2 diabetes. From the standpoint of the cost to the economy, new research estimates that $105 billion is wasted annually on medication therapy nonadherence of which 69%—or $72.5 billion—is spent on hospitalizations. Other findings project that poor medicine adherence, along with suboptimal prescribing, drug administration, and diagnosis, costs the health care system an estimated $290 billion per year in avoidable medical spending and lost work productivity, translating into 13 percent of total health care expenditures.
The future state of medication adherence will be affected by the move towards a patient-centered health care system through implementation of the Patient Protection and Affordable Care Act (ACA), including efforts to reduce avoidable hospital readmissions, which is driving innovative approaches to medication management.
A NEW ADHERENCE ACTION AGENDA
NCPIE’s Adherence Action Agenda advocates for an increased focus on the overlooked challenge of multiple chronic conditions, where the need for patient adherence is most acute, and lays out these ten policy and programmatic solutions to improve medication adherence:
1. Establish medicine adherence as a priority goal of all federal and state efforts designed to reduce the burden of multiple chronic conditions. Because patient adherence is not viewed as an essential element of government initiatives to reduce the burden of multiple chronic conditions, the report calls for adherence to be integrated throughout the range of efforts now underway through a new HHS Multiple Conditions Strategic Framework to improve health systems change and facilitate new research efforts.
2. Establish the role of the patient navigator within the care team to help patients with multiple chronic conditions navigate the health care system and take their prescription medicines as prescribed. Building on the patient navigator model now used in hospitals and cancer clinics nationwide, the action plan advocates for pairing patients treated for multiple chronic conditions with specially trained adherence navigators who will, in collaboration with patients and caregivers, obtain the patient’s medical records, create an accurate medication list, set up medication counseling as needed, schedule timely follow-up physician visits, and facilitate communication between the patient and his or her different physicians.
3. Promote clinical management approaches that are tailored to the specific needs and circumstances of individuals with multiple chronic conditions. Since patients with multiple chronic conditions differ in the severity of their illnesses, prognosis, and functional status, the report encourages health professionals to adopt the American Geriatric Society’s guiding principles for treating older adults with three or more diseases, which calls for eliciting and incorporating patient preferences and choosing therapies that optimize benefits and minimize the harm for older patients.
4. Incentivize the entire health care system to incorporate adherence education and medication support as part of routine care for MCC patients. With research showing that the interactions between patients and their healthcare providers affect how well patients manage their chronic conditions, the report advocates for an expanded investment in patient/provider education and engagement tools to help clinicians implement best practices for medication adherence and counsel their patients on the importance of following treatment plans.
5. Eliminate the barriers that impede the ability of patients with multiple chronic conditions to refill their prescription medicines. One of the reasons patients fail to refill their prescriptions is the need to pick up prescriptions at different times and sometimes at different pharmacies, requiring numerous trips. T o reduce these obstacles, stakeholders support implementing the “pharmacy home” model, which gives patients a single pharmacy point of contact for filling prescriptions, and adopting refill synchronization, which allows patients to fill different prescriptions at one time and therefore, reduce the number of visits they must make to the pharmacy.
6. Reduce the cost-sharing barriers for patients by lowering or eliminating patient copayments for prescription medicines used to treat the most common chronic diseases. The report makes clear that the cost of medications for some patients is a barrier to filling their prescriptions and taking their medicines as prescribed and advocates adopting policies that will reduce the out-of-pocket costs for medications, especially for patients on multiple prescriptions for chronic conditions.
7. Accelerate the adoption of new health information technologies that promote medication adherence. Because significant innovations in health technology have the potential to improve the flow of timely and complete information on medicine use between patients and providers, the report calls for the swift adoption of new standards for using electronic health records, incentivizing providers to use health information technology to identify patients at risk for medication misuse, and the expanded use of electronic reminders and personal health records to improve medication adherence.
8. Establish medication adherence as a measure for the accreditation of healthcare professional educational programs. Currently, the nation’s medical residency programs are moving towards an outcomes-based accreditation system, where medical residents will be evaluated on the basis of required core competencies, including interpersonal skills and communication. From the standpoint of medication adherence, this represents an opportunity to integrate medication management and e-prescribing into the curriculum of medical residency programs and paves the way for establishing medicine adherence skills as core competencies within the curricula of schools of pharmacy, nursing, and other allied health professions and as an accreditation measure.
9. Address multiple chronic conditions and optimal medication management approaches in treatment guidelines. Clinical practice guidelines typically focus on managing a specific chronic condition and do not take into account the presence of multiple chronic conditions. The report advocates the accelerated development of updated treatment guidelines where information is included on the most common comorbidities clustering with the incident chronic condition, this can start with the most common combinations of multiple chronic conditions, called dyads and triads, which have already been identified by the Centers for Medicare and Medicaid Services (CMS).
10. Stimulate rigorous research on treating people with multiple chronic conditions, including focused research on medication adherence to promote the safe and appropriate use of different medicines in this patient population. There is a paucity of evidence-based data on how to treat patients with two or more concurrent diseases who are taking drugs developed and tested in people who have a single condition. Accordingly, the report supports incorporating medicine adherence throughout the research agenda for multiple chronic conditions and advocates for increasing the budget for HHS research efforts examining the best ways to treat the most prevalent clusters of concurrent diseases.
Because the stakes are so high, the report lays out a new Adherence Action Agenda to coalesce stakeholders around the common goal of improving patient adherence to reduce the burden of chronic disease. Ultimately involving the support and active participation of many constituencies—the federal government, state and local government agencies, professional societies and healthcare practitioners, health educators and patient advocates—it is hoped that this report will serve as a catalyst for action and provide a blueprint for accelerating progress.
This is thoughtful and actionable plan and the complete report is worth a careful read and candid debate.
From the pages of the San Jose Mercury News ...
Antibiotics in animals: In food safety, a noteworthy policy consensus
By Peter J. Pitts
It's always a surprise -- and therefore newsworthy -- when opposing groups in Washington, D.C., find common ground and a policy moves forward at the national level.
That's what happened recently when the Food and Drug Administration published documents implementing its policy that medically important antibiotics should only be used when there's a disease or a disease threat. As a result, "growth promotion" uses will be phased out over the next three years. An accompanying rule will require a veterinarian to oversee the use of medically important antibiotics in feed.
The policy ensures antibiotics that are similar to those used in humans will be used in animals in the same way: to address a specific disease or disease threat, and only under the supervision of a licensed medical professional. It affects farms nationally, making state-based efforts -- including those in California -- unnecessary.
This collaborative effort is noteworthy for animals, veterinarians and the millions of Americans who depend on those animals for food supply.
The FDA and animal health representatives share broad agreement on this national position. Animal health organizations, along with the companies that develop animal antibiotic medicines, have supported the policy since its inception and announcement in 2012. Consumer organizations that have criticized the use of antibiotics in agriculture asked for this policy in a letter to the White House in 2009 and supported the FDA's announcement.
While some have criticized the policy as being voluntary, the fact is that the FDA has succeeded because it pursued its agenda in a collaborative way. The agency met with everyone involved, including farmers and ranchers, the pharmaceutical industry and consumer groups, to understand and address concerns.
As a result of this collaboration, the agency has enacted change more quickly than with a regulatory or legislative approach. On the day the agency released the documents, the two largest companies selling these products publicly announced their support and cooperation. Other companies have 90 days to make their intentions known.
The other benefit of this collaborative approach is that it should avoid the unintended consequences that resulted when Europe legislated a ban on growth promotion uses of antibiotics. That ban resulted in increased animal disease and death. The FDA's collaborative approach gives farmers and ranchers the chance to adjust to these changes more gradually and avoid these negative consequences.
The policy is a significant change in the way antibiotics are used to keep food animals healthy. It is unfortunate that many seem to think that antibiotics are used only "to fatten animals." That's not true, but now no medically important antibiotics will be used to promote growth. In addition, no antibiotic will be used in feed unless a licensed veterinarian verifies that it is needed to treat or prevent a disease.
Consumers should be heartened by this development. While eliminating what the FDA believes to be unnecessary uses of antibiotics, the limited and important uses needed to protect animal health with continue.
That's important, because animals get sick -- just like humans do.
Farmers and veterinarians work hard to prevent disease and avoid the use of medicines to treat disease. We all know that there's a nexus between animal health and human health, and the food supply is one of the key areas of that nexus. Farmers and veterinarians need a variety of tools to keep animals healthy because healthy animals help produce safer food.
The FDA has made significant progress on a divisive issue. As a result, consumers benefit from knowing that antibiotics can only be used to address disease challenges in food animals under the supervision of a veterinarian.
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.
