Fate of biosimilar drug industry tied to health bill
Hamster ovaries, mare's urine, pig intestines, blood. It's not a recipe for a witch's stew — they're all components of high-tech biologic drugs. Used to treat everything from cancer to arthritis, biologics are the fastest-growing class of medicines, with more than $40 billion in annual sales in the United States. But they're also expensive — many cost tens of thousands of dollars a year — and the FDA has no authority to approve lower-cost, generic versions. That will change if the health care bill is signed into law.
Good prediction: FDA targets counterfeit drugs
But new import tracking system alone can't stop the massive trade in faked pharmaceuticals.
Colliding, again, with the First Amendment
As the FDA charges after speech-based conduct, the public may lose out on valuable info.
FDA announces potential changes to medical device regulatory process
Controversy and uncertainty arise because new measures will likely increase the regulatory burden and delay clearances.
Don't take a bite out of health claims
Lack of FDA clarity undercuts business's ability to spread good news about food.
