Patient Group’s Success Developing Drugs Earns Kudos, Criticism
About 15 years ago, the Cystic Fibrosis Foundation began investing in a biotechnology firm to develop drugs to treat the lung disease. That funding has produced new drugs, but their price tags have spurred criticism of the group, reports The New York Times. Meanwhile, the FDA delays a rule for updating generic drug labeling.
The New York Times:
Payout From Drug Raises Questions For Cystic Fibrosis Group
About 15 years ago, the Cystic Fibrosis Foundation made what was considered a risky foray for a nonprofit organization into the world of business. It began giving money to a small biotechnology company to entice it to develop drugs for the deadly lung disease. But that funding, a total commitment of $150 million, has now paid off enormously. The foundation is to announce on Wednesday that it will receive $3.3 billion from selling the rights to the royalties to those drugs. That is 20 times the foundation’s budget last year. (Pollack, 11/19)
The Wall Street Journal's Pharmalot:
FDA Delays Final Rule On Allowing Generic Drug Makers To Update Labels
A controversial new rule for updating generic drug labeling that the FDA was expected to finalize next month will not be published until the fall of 2015, an agency spokeswoman says. The rule, which the FDA proposed last year, would allow generic drug makers to independently update safety warnings, something that only brand-name drug makers can currently do before receiving FDA permission. (Silverman, 11/18)