Legal

If it looks too good to be true.... The price is unbeatable, the Web site proudly displays an accreditation seal of approval, medicines are advertised as "generics" of the branded versions (implying bioequivalence with respect to safety and efficacy), and patients never have to leave their homes. Marcia Bergeron, a 57-year-old Canadian resident likely had these things in mind when she purchased antianxiety and sedative medication from an online pharmacy. The pills she received from the Web site, however, caused hair loss and vision problems, and ultimately resulted in her death. The coroner's toxicology report showed that the pills she purchased online were laced with traces of dangerous metals, including uranium, strontium, selenium, aluminum, and arsenic. Bergeron, like many others around the world, was a victim of the counterfeit-medicine business, an industry that the US-based Center for Medicine in the Public Interest (CMPI) predicts will reach $75 billion in sales globally by 2010.

Compliance requires overcoming cultural barriers. To start with, in some countries the taboo against bribery is not as strong as it is here.

Documents from R&D, clinical affairs, regulatory, and sales and marketing can be in the millions. Throw electronic information into the mix, and the number of documents required for litigation increases exponentially.

When one company purchases another's branded trademarks as keyword search terms, the goal is to lure consumers to the buyer's site.

In cases that reached a verdict between 2002 and 2006, the branded pharma industry won six of six cases by verdict in Delaware, but lost six of eight in New Jersey, all by summary judgement. Despite what judges say, it's no coincidence.

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.