| Consequences of FDA approval |
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FDA decisions are extremely important in the US. FDA approval is necessary to advertise a drug. FDA approval influences insurers’ decisions about drug payment. FDA approval requires physicians to educate themselves about new drugs. Lack of FDA approval can be used by critics of MSM, people who fear risk compensation, or market competitors to deter MSM from using PrEP. FDA approval is irrelevant in informal drug markets or when drugs are unaffordable.
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It’s not like it’s just like a scary, unapproved drug, which I’m sure like many people are gonna try and frame it, people that would strive to… keep others from accessing it… like, probably people who are just, like, uncomfortable with men having sex with men… or people… like medical professionals… who are afraid this is gonna… lead to decreased condom usage and more transmission of like, other types of STIs. (FG063, age 21, NSW*) Maybe that’s why they’re not advertising it, because the FDA hasn’t approved it… That’s false advertisement, so there’s no way they can put up flyers saying this drug prevents HIV because it’s not been approved for that usage. (FG087, age 40, SW**) The street pharmacist doesn’t wait for FDA approval. (FG052, age 47, NSW) Let’s say they do pass that, the FDA approves it, it comes out tomorrow – not too many people are going to spend $700 a month for that.… If insurance don’t cover it, there’s no way. (FG047, age 39, NSW)
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| Direct influence of FDA approval on PrEP acceptability |
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FDA approval is necessary before taking PrEP. Lack of FDA approval is a deterrent to using PrEP. FDA approval of TDF-FTC for HIV treatment is insufficient; approval for prevention is also necessary before taking PrEP. FDA approval of TDF-FTC for treatment is sufficient; approval for prevention is unnecessary. Lack of FDA approval is not a deterrent to using PrEP. FDA approval is less meaningful than consulting with a physician or reading peer-reviewed journals. FDA approval is less relevant for individuals who are HIV-positive, or for whom approved medications are ineffective or toxic.
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My personal opinion, I would wait ‘till the FDA approved it just to be safe. It would make my mind more relieved knowing that the federal government approved it. (FG078, age 61, NSW) Participant: I take enough bad things without anything being approved. Why should I add something that the government’s going to be telling me that they’re not sure of? Facilitator: Even if they’re okay with it for treatment? Participant: Yeah… I’d be, uh, skeptical of it, you know… I’d have to know more. (FG037, age 60, NSW) The fact that [TDF-FTC has] been approved for a purpose and is being used for a related purpose, it would be fine by me. I would just want to, for my own curiosity, see more of the research. (FG036, age 48, NSW) I don’t think [FDA approval makes a difference]… I mean, if it works, it works.… If the drug’s already on the market and they’ve deemed it safe for people to ingest, I guess I mean if you want to use it for your own purposes, I don’t see why not. (FG039, age 29, NSW) A chance of it working is better than nothing, you know what I mean? (FG060, age 26, SW) I would rather see it in like – like peer-reviewed journals… I don’t really care about the FDA approval. (FG046, age 28, NSW) The non-FDA approval wouldn’t deter me, but as far as discussing it with a medical professional, I would never be embarrassed about that. (FG055, age 33, SW)
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| Meaning of FDA approval |
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The FDA has complete information about a drug. The drug is appropriate for human consumption. The side effects will not be immediately lethal. The drug has been tested to prove effectiveness. The information provided to consumers is valid and complete. Using an unapproved or off-label drug is like participating in an experiment. FDA approval does not reliably signify safety because the FDA has a profit motive to approve dangerous drugs; science may eventually prove the drug is unsafe; and drug manufacturers make mistakes.
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The FDA and all that, they ain’t gonna approve nothing unless they know everything about it. (FG004, age 47, NSW) If it gets FDA-approved, they would tell you all, like, the side effects and things of that nature… [I]f it’s not approved, they’d just be giving it to us and not telling us anything… you get better information [when a drug is approved]. (FG081, age 44, NSW) I would definitely do it even though it was not FDA-approved… I don’t mind donating my body to science… I don’t mind being a guinea pig. (FG042, age 28, NSW) They move a lot of our pharmaceutical companies to other countries now… so there’s been a lot of mistakes made… So don’t take that, just because it says ‘FDA,’ that everything’s all right with that, ‘cause it doesn’t necessarily mean it is, you know? (FG087, age 40, SW) [FDA approval matters] because it hasn’t been proven… isn’t that what it means, that it’s been tested enough times to where it scientifically proves that it’s effective? … It’s not hazardous. (FG090, age 28, SW)
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| FDA motivations and procedures |
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The FDA has a profit motive and is susceptible to the lobbying of drug manufacturers and industry actors such as condom manufacturers. The FDA fears risk compensation behavior among MSM, making approval less likely for HIV prevention drugs. Approval procedures are antiquated and lengthy, and the delay is harmful to the population. The long duration of FDA processes means that drugs are outdated before they are approved. The US FDA is less likely to approve an HIV prevention drug than drug approval bodies in other countries. The FDA conducts safety and efficacy research itself.
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[T]he FDA and the drug business is one of the most awful bad, bad, bad, bad, like industries in -- in our country, you know? It’s mostly about money, period, point blank… Constantly the FDA approves medications that seriously harm people and mess them up for the rest of their life.… So of course, if they haven’t approved [PrEP] yet, God knows what could happen to you. (FG066, age 29, SW) I think this government, the FDA or whatever you want to call it, is afraid of, if some pill came out like that, of how people are going to act… if they did approve something and people felt that well, you can’t get HIV no more… people are gonna be havin’ sex galore… So it’s hard for them to approve that because then they think everybody’s going to go crazy. (FG047, age 39, NSW) I think they drag their feet. Like, you know, you look at like, England, and they’ll have medications out two, three years before we even approve it. By that time, something new has come along that – that overrides what the FDA just approved for us, you know. (FG003, age 53, NSW) I understand FDA approval, and I understand all of that, but I mean… do you know how many people’s heads I held why they were dying with AIDS? … [W]e’re ready for this, like let’s do something, but it doesn’t seem to be here. (FG052, age 47, NSW) Participant A: When it comes to every time that I’ve came across, in Brazil, they found a pill, or some scientist that prevents HIV, monkeys haven’t even gotten it… FDA doesn’t approve it… When it’s for positive, they’re very good at ‘okay, sign off, approved’ … but when it comes down to negative to prevent it … they’re very hard to sign a paper… They’re afraid. Participant B: Europe is a lot lenient – more lenient. (FG047, FG049, both age 39, NSW)
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