Commissioner Gottlieb Vows Action: Says Drug Makers Gaming System to Slow Generic Competition

USA Today reported on August 15 that “Drugmakers ‘game the system and game the rules’ through a patient safety program that allows them to keep generic drug companies from getting enough doses of their branded drug, said Gottlieb. Generic drugmakers need up to 5,000 doses to do the studies needed to prove their products are truly equivalent, he said… FDA has received about 150 letters that generic companies have sent brand name companies complaining about access to doses for their studies.” Only about half involved the patient safety program, while the others involved specialty pharmacies and restrictive contracts that prevent distributors from selling to generic companies.

This seems anti-competitive to him, but even if it isn’t illegal, Gottlieb said, “there are ways FDA can address these tactics because it’s good public health policy. One way is releasing the letters publicly, which FDA plans to do.” Here’s a link to the full story and a link to contact us if you need help with your complex generic.