Generic medications are safe and effective, just as their brand-name counterparts, and often cost less, providing consumers and the healthcare system significant savings.

Lack of awareness about generic medications and the stringent FDA application review process may lead patients to continue to use brand-name medications, even when more affordable generics are available. These misconceptions may also cause patients who are “switched” to a generic drug not to take their generic treatment. Both instances may lead to a decrease in medication adherence and, ultimately, worse health outcomes. 

In this CDER Conversation, Iilun Murphy, Director of CDER's Office of Generic Drugs (OGD), discusses how OGD is conducting and funding research to better understand how we can best educate patients and health care providers about generic drugs.

How is OGD working to understand patient perceptions of generic drugs?

OGD conducts internal and extramural research to better understand public perceptions and educational efforts about generic drugs. One goal with this research is to help develop educational materials that promote confidence in generic drugs to improve generic drug medication use and adherence. 

Generic medicines and brand-name medicines share the same active ingredient, but due to allowable minor differences, generic drugs may look or feel different than their brand-name counterparts (e.g., color, shape, or size of pills). When patients are switched to a generic drug, they may notice certain changes in their drugs' appearances, which can result in confusion. Studies indicate that patients are more likely to stop taking their generic medications when they experience a change in their drugs' physical appearances. In the case where a patient experiences a change in the design of a drug delivery system for a complex generic (such as an inhaler), they may also have concerns.

Many studies that assess patient perceptions of generic drugs rely on surveys. At times, OGD uses qualitative research, a type of exploratory research that attempts to understand participant views, perspectives and behavior, to gain greater insight into patient perceptions of generic drugs and generic substitution beyond what a survey would capture. 

What is a recent example of such qualitative research?

OGD recently published a qualitative study conducted among focus group participants with chronic obstructive pulmonary disease or asthma who were actively using a brand-name dry powder inhaler (DPI) to explore patients’ attitudes about and perceptions of generic DPI substitution for the brand-name and patients’ views of generic drug quality, efficacy, design, and usability. 

In each focus group session, a moderator began by generating discussions with the participants about their overall perceptions of generic drugs. Afterwards, the moderator presented a hypothetical scenario to the participants through a journey mapping exercise in which their pharmacy unexpectedly replaced their current brand-name DPI with a generic DPI for the first time. Throughout the study, participants described their thoughts, feelings, and other reactions of switching to a generic DPI.  Participants could physically see and hold both a brand-name DPI and a generic DPI. This hands-on comparison facilitated the discussion about potential questions and barriers of switching to a generic DPI.

Overall, we found that patients viewed generic drugs as more affordable and cost-effective than brand–name drugs, in part, because participants thought generic drugs were more likely to be covered by insurance. Participants generally suggested that generic medications were similar to their brand-name counterparts, with the same active ingredients, although perceptions of efficacy, safety, and quality were mixed. Many of these perceptions were caused by uncertainties about how generics of a drug differ from the brand-name.

Most participants in the study also commented on the look or feel of the generic DPI device, which was slightly different than the brand-name DPI device and considered how this difference may affect their use of the device. Often, these aspects tended to relate to convenience (i.e., fitting the device in a purse) and ease of use (i.e., fewer steps to perform) more so than proper use. However, participants showed some hesitation in their ability to properly use the generic device, particularly for the first time.

In line with previous studies, participants expressed some negative perceptions of switching from brand-name DPIs to generic DPIs, but much of the negativity seemed to stem from the fact that they were not first asked or informed about the switch. Nonetheless, in many cases, participants seemed willing to change to the generic DPI, particularly if they thought there would be a financial benefit.

What did CDER learn from the study?

Outcomes from these focus groups revealed opportunities for FDA, health care professional organizations, and patient advocacy organizations to improve generic drug literacy among adults, adolescents, and health care providers. In addition, our results support the need for ongoing research by FDA and other research organizations to expand scientific understanding of how differences in design and usability between brand-name and generic DPI devices affect patients’ abilities to navigate a switch to a generic of their inhaler medication and use it correctly without additional training or instruction.  This type of research helps support FDA’s ability to approve drugs that have minor differences in design and usability that do not affect outcomes for patients, especially complex generics such as inhalers which are more challenging to develop.

Greater education and outreach to patients about generic drug standards could help dispel misconceptions about the quality and effectiveness of generic drugs. This, in turn, will promote the use of generic drugs, leading to improved medication adherence and better patient outcomes.

How can patients learn more about generic drugs?

To help educate patients about FDA’s rigorous review process, the economics of pricing, and related issues, FDA offers a range of educational materials, including videos, graphics, fact sheets, and related resources. 

We encourage patients to talk with their health care providers about prescribing generic drugs when the option is available. In addition, there are ways for patients to find out if there is a generic of their brand-name medicine available. Patients may search for the generic name (e.g. “fluticasone propionate” or “salmeterol”) of their medications online at Drugs@FDA, Dailymed, or Orange Book to see if there is a generic available. Patients can also call FDA’s Division of Drug Information to ask a pharmacist about generic options for their current medications. The Division of Drug Information is available Monday – Friday, 8:00am-4:30pm ET by phone at 855-543-3784 or 301-796-3400 or by email at [email protected].