Does the FDA have the authority to deny marketing approval for minor improvements? Mylan pushed generics off the market by making a better cap or something, the FDA should just say no, that improvement is nice but it isn't enough to give you exclusive marketing rights. If you want to incorporate it into your product, license it to your competitors for cheap.
>> Does the FDA have the authority to deny marketing approval for minor improvements? They certainly don't. Look at Nexium, it is something close to a blatant scam but the FDA approved it and between Medicare and Medicaid alone the federal government has rewarded the scammers (AstraZeneca) with billions of dollars never mind private insurance companies.
The additional issue with auto-injectors is that knowing how to correctly use a particular one is important, so there is a legitimate reason to make sure that generics work the same way as the branded version. This means that if the branded version adds a patented safety feature, then there won't be generics for a while.