
. . . may be bad news for pharmaceutical companies. As President Obama unveils more details about his healthcare reform agenda, it becomes clear that he is not going to give up on his aim to provide greater access to generic medicines.
Under the current law, drugmakers are allowed five years of exclusivity for new drugs, and three years for new formulations of existing products. Obama’s budget proposal calls for the creation of a biogeneric pathway, aimed at reducing healthcare costs by increasing access to quality care at affordable prices. Under the new rules, brand biologic manufacturers would be prohibited from reformulating existing products into new products to restart the exclusivity process, a process known as ever-greening.
Some drugmakers had also been pushing for an extension to the five-year exclusivity period – up to as long as 14 years – arguing that five years is not enough time for them to recoup the tremendous cost of developing new drugs and make a decent profit. They say that any move to tighten up on exclusivity will stifle innovation.