Legal

Indeed, at this time, we are aware of no evidence that the practice of authorized generics has actually deterred any Paragraph IV certification or post-180 day generic entry, let alone a challenge to an invalid patent.

Scott Gottlieb called RFID implementation "disappointing." Now, FDA is moderating its view of RFID as a cure-all for the industry.

Criminal penalties for violating the Foreign Corrupt Practices Act can be substantial. Businesses found guilty may be fined upwards of $2.5 million for each offense, or twice the amount gained as a result of the violation.

Drug manufacturers should have policies against sexual harassment of sales reps. Such a policy may also help counter charges that a company is implicitly encouraging its reps to use their sexuality as a sales tool.

The omission of criminal charges for off-label promotion of Serostim is surprising, because the government's earlier plea with Pfizer sent a strong signal that it would criminally charge companies engaged in off-label marketing.

Under one bill, states could license patented drugs to generics companies, paying patent holders a royalty.

Class actions threaten industries that deal with the public. If European lawmakers remove the restriction on class-action suits, consumers will be free to file cases. Pharma companies should take heed.

Plantiffs did not try to establish a link between the purported misconduct and the decline in share price. Rather, their sole allegation was that they had paid artificially inflated prices for Dura securities.