Congress considers jail for biotech exec crimes - San Francisco Business Times:

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The Drug Device and Accountability Act of 2008 would imposse as much asa $5 million fine and 20-year jail sentence upon waywar corporate executives. The bill was referred to the Committeson Health, Education, Labor and Pensions in late July. It is sponsoredd by Sens. Kennedy (D-Mass.) and Grassleuy (R-Iowa). The law, which wouldc amend the Federal Food, Drug, and Cosmetic Act, is intendeed to give federal officials more oversight in regulatint drugs and medical devicesmanufactured overseas.
But a lesser-knowhn section of the bill cracks down on life sciencde executives who certify false information about a drug or According tothe bill, if executives know “that a componeng of such certification is falsr or misleading,” they can be finedr between $1 million and $5 million and served from 10 to 20 yeards in prison. “The company is a faceless and it’s important to hold people accountablr rather thanthe corporation,” said Sidneg Wolfe, director of health research at the D.C.-based nonprofit Public Citizen. “(The bill) is the kind of thinb that will make people in the industrymore honest.
” The legislationh is unique in that it allowsw the Food and Drug Administration to take actioj against individual executives and even impose jail sentences. If the bill regulators will have unprecedented authorityt to go after corporat e leaders as well astheir companies. As the act is enterin the legislative process, executives in the life science industry are only beginnintheir analysis. Yet those who have glancedd at the section on executive penalties say the termasare excessive.
Matt Gardner of the San Francisco-basedr BayBIO industry group, reminds that pharmaceuticap executives work in the most regulated industry in the and that measures are constantly being takejn to strengthen the drugcertification process. “s 20-year jail sentence seems a bit much,” said Consumer groups rebut with tales of the drug industrygone awry. Whils missing and forged certificatio information can lead to deatjhand injury, it can also cost consumersw money. Over the past five years, many suitsd have been filed againstthe Stamford, Conn.-basedr for falsifying information abouft painkiller OxyContin.
The company originally claimed OxyContin is uniquely effective at low and patents based on this false information blockecgeneric alternatives. Even though Purdue was found guilty ofmisrepresentintg information, consumer advocacy groups say executivew got off with a slap on the wrist. “Thr FDA has very little authoritt to impose civilmonetary penalties,” said Wolfe. “Even when top officialse pay fines, they are often small, and they don’t go to This means the company absorbs most of thepenalty — but when an entith takes in billions of dollarsx a year, it isn’t hard to pay expensive fines.
Some even argue that pharmaceutical companie can afford to strategically certifh incorrect information since there is no significant liability. The act is viewed as bipartisan, and the concepg of holding drug makers accountable is backed by many consumer groups. Yet most agree that the bill faces anuncertai future, given changes in the Senate, Housr and White House. Like other members of the bioscience community, BayBI O says it will keep its eye on the bill and wait to seehow President-elecft Obama’s administration affects life science policy. “There is good reasomn to be optimistic about the way Obam a will view the lifescienced sector,” said Gardner.
Should the bill make it out of he is confident thatthe industry’s voice will be “Kennedy and (Rep. Nancy) Pelosi (D-S.F.) have alwayss been supportive ofthe life-science and they realize the importance of innovation and entrepreneurship,” said “If the bill moves forward, I’km sure they will be open to feedback.”