FDA announced in today’s Federal Register (FR) that they will conduct a survey of patients and pharmacists to gain an understanding of both groups’ perception of certain attributes of differences in generic medicines for the same drug product. See the full FR notice here.
This survey comes on the heels of Office of Generic Drug Guidance (OGD) on size, shape and color of generic products (here), issued last December. FDA has received complaints and feedback from numerous patient and health care providers on various aspects related to differences in the physical characteristics of generics when they are initially switched from the brand name product (when initial substitution occurs) as well as when switching to other generic manufacturers of the product on subsequent refills. Historically, FDA never really regulated such attributes and it has permitted generic applicants significant leeway to choose their product design unless it posed some obvious safety issue. Generic firms began developing differences in these attributes more consistently after the passage of the Hatch-Waxman Act in an effort to avoid trade dress infringement and to design around patents. As time marched on, FDA today clearly believes (and rightfully so) that these changes in attributes of generic products may impact on the medication compliance or (at a minimum) raises a question about whether the appropriate medication have been dispensed by the pharmacist. These product differences (or the resultant confusion they may cause) seem to occur despite the auxiliary warning labels, and counseling or other information provided by the pharmacist at time of dispensing. Patients continue to question color, size, or shape changes when product substitutions are made, and, if the tablet or capsule is substantially smaller or larger than what they have been getting, they may worry that the wrong strength of medication or wrong drug has been dispensed. Problems with swallowing a larger tablet or capsule could also lead to poor compliance or noncompliance with prescribed medication regimens.
FDA says in the FR notice that they intend to conduct these surveys “[T]o provide additional information that may help guide regulatory policy or pharmacy business practices, we intend to conduct surveys of pharmacists and patients about their perceptions about and experiences with generic drug product pill appearance change.”
The survey for pharmacists is designed to obtain both the pharmacist’s perception of changes in color, size, and shape of generic medications when a change is made in the manufacturing of the generic product dispensed, as well as the pharmacist’s view of the reactions of their patients to such changes.
The pharmacist survey will enroll a national cohort of pharmacists who practice in traditional community pharmacy settings. FDA’s goal is to survey enough pharmacists to obtain 1000 completed surveys. The survey is estimated to take about 20 minutes for the pharmacist to complete.
Patient surveys will be conducted by phone in two groups – patients 50 years of age or older that have certain chronic conditions and take certain therapeutic categories of drug products (e.g., antiepileptic hypertension, depression, HIV drugs). A second group of patients will be derived from a national database of patients with at least one chronic disease whose medication has changed in one of the attributes to be studied.
It appears that FDA is attempting to quantify problems that such changes introduce that may effect the patient’s compliance with prescription drug therapy, and possibly to identify specific types or therapeutic categories of drug products for which such changes are most troublesome to patients. Depending on the results of the study, FDA could review and/or revise its policy on generic product changes and may either increase requirements on sameness of products or lessen the burden on industry if they find that certain changes do not impact drug therapy compliance.
This is a very perplexing issue that the Agency and industry are dealing with. The impact on patient safety and efficacy are of paramount importance but clear guidance from FDA is necessary for the generic industry to efficiently develop the products for which it will seek FDA approval. If the rules change in the process of product development, then clearly the industry may be forced to go back to the drawing board to revise the specific characteristic to which FDA may object. Could the policy change based on the result of the survey? Certainly! Could regulation be far behind? Quite possibly! All we can do is wait and see as the paradigm shifts more towards a true “copy” of the innovatory product.