The folks at the American College of Physicians this month touched off a debate among physicians in internal medicine by updating their ethics manual and calling for doctors to provide “parsimonious care,” that is, “to practice effective and efficient health-care and to use health-care resources responsibly.”
The concept is not entirely new. But if there was any question that the (possibly imaginary) era is over when physicians’ and patients’ lone focus in choosing treatment was what’s the best option for the patient, with little attention to the costs involved, that question is settled.
Ophthalmologists may not routinely face the weighty choices regarding treatment costs that cardiologists and oncologists deal with. But it was also reported this month that about 5 percent of our population accounts for nearly half of federal spending on health care. The typical resource-devouring patients among the 5-percenters: white, non-Hispanic women in poor health; the elderly; and users of publicly funded health care. In other words, the typical waiting-room population of most general ophthalmologists and cataract surgeons. Now, your care is admittedly only part of those patients’ deductions from the health-care budget. But, for once, this month you have an opportunity to influence how federal regulators apportion health-care dollars in your profession.
On February 27, the FDA’s Dermatologic and Ophthalmic Drugs Advisory Committee will convene to address topics related to the use of ophthalmic drug products. The committee will be asked to comment on two topics related to the use of ophthalmic drug products:
The first concerns the appropriate types of clinical evidence for developing nonsteroidal anti-inflammatory drugs for the treatment of postoperative pain inflammation and reduction of ocular pain in patients who have undergone cataract surgery.
Currently, the FDA’s Center for Drug Evaluation and Research requires that ocular anti-inflammatory drugs achieve statistically significant differences versus placebo in the proportion of patients achieving complete resolution of a sign (complete resolution of cells and flare by post-surgical day 14) and a symptom (complete relief of pain by day one) to receive a label for the treatment of post-cataract inflammation and relief of ocular pain associated with cataract surgery. This includes both ophthalmic steroid and ophthalmic NSAID classes of drugs.
However, no other types of ocular surgery are included in this labeling, and it is assumed that to receive an indication for additional types of ocular surgery, each individual type of ocular surgery would have to be studied in order to get approval on a label for these indications. FDA requires two additional adequate and well-controlled clinical trials to expand the labeled indications of a product. This means that the use of anti-inflammatory drugs for surgical conditions other than cataract surgery is off-label. For example, currently all steroids, with the exception of Durezol, when used for inflammation related to surgical conditions, are off-label.
The second issue before the committee involves the appropriateness of marketing a single bottle of ophthalmic product for both eyes for post-surgical indications as it relates to the potential risk of infection. CDER would like the committee to provide advice on the potential risk, including limits to fill size where appropriate.
In essence, the FDA is asking the committee for advice on whether the agency should limit fill sizes of NSAIDs to a bottle size that provides only enough drops to treat the labeled indication (e.g., the treatment of inflammation and reduction of ocular pain following cataract surgery, which equates to 16 days of therapy) for a single eye. Currently CDER’s position is based on their hypothesis that users may touch the dropper tip to the eye, thereby spreading bacteria from one eye to the other, hypothetically causing ocular infection. However, this goes against standard ophthalmic practice and experience, particularly with extended use of products for off-label, standard-of-care uses (e.g., prophylaxis of CME). FDA itself continues to approve some products with larger fills for both eyes (e.g., Lotemax 0.5%) and not others (e.g., Bromday). At the present time there are at least eight ophthalmic products that are provided in a fill size sufficient to treat two eyes and which have labels instructing the patient to apply to the “eye(s)” or “conjunctival sac(s). These products include Acular, Acular LS, Lotemax, generic ketorolac ophthalmic solutions, prednisolone acetate suspensions, diclofenac, and Durezol among others. So establishing a standard approach is an important part of this question, presumably.
The agency intends to provide background material on these questions and its positions on them to the public no later than two business days prior to the meeting. Other issues may be brought up at the hearing but will not be made public by the FDA until 24 hours before the meeting.
The FDA has opened a docket for public comment on this meeting. The docket number is FDA-2011-N-0805. The Docket will close on March 5, 2012. Interested parties may submit data, information or views, orally or in writing, on these two issues. Submit electronic comments to the website, regulations.gov. Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers La., Rm.1601, Rockville MD 20852. All comments received will be posted without change including personal information provided.
Topical ophthalmic drugs are not headline-making issue and aren’t bankrupting the system. But, for once, you don’t have to try to turn the battleship. You can provide real-world input that may affect study design and drug development, off-label use (and any associated reimbursement or medico-legal risks), reimbursement, patient cost-of-care, sufficiency of drug supplied for standard of care and others.