By Kim Coghill
WASHINGTON ¿ All the conversation about suspending Bayer AG¿s patent on the anthrax drug Cipro would not have taken place if legislation proposed by Rep. Sherrod Brown had been signed into law.
Under his legislation, the government would have the right to take a patent under the guise of a national health crisis.
Brown, a Democrat from Ohio, Wednesday proposed legislation known as the Public Health Emergency Medicines Act, which would allow the government to take a company¿s patent or technology in the event of a national or global health-related crisis.
¿This bill is much broader than his previous bills,¿ Lila Feisee, director of intellectual property for the Washington-based Biotechnology Industry Organization (BIO), told BioWorld Today. Brown¿s Affordable Prescription Drugs Act of 1999 would have given the government similar authority.
According to this new proposal, ¿the secretary [of Health and Human Services] could come in ¿ without your authorization ¿ and take your technology, export it and give you reasonable compensation based on a variety of different criteria,¿ Feisee said. ¿All the government would have to say is, We perceive an anthrax outbreak,¿ and they could come in and take your technology.¿
She went on to say the bill would be ¿devastating¿ to the biotechnology community because investor funding likely would dry up.
Ted Miller, a spokesman for Brown, said the legislation is an outgrowth of the anthrax scare and the congressman intends for the bill to stand on its own, but is willing to attach it to a bioterrorism bill.
Senators Propose Entering Vaccine Business
Also on the bioterrorism front last week, senators Ted Hutchinson (R-Ark.) and Judd Gregg (R-N.H.) introduced a bill that would let the administration enter long-term contracts for vaccine development and ensure that bureaucratic delays would not keep potentially life-saving treatments from the public.
Referred to as the Pathogen Emergency Preparedness and Response Efforts Act of 2001, or the PREPARE Act, the legislation also would give the FDA the authority to designate ¿anti-bioterrorism¿ products for fast-track approval.
And the bill requires the government to publish a list of chemical or biological agents and toxins that can be used against the citizenry.
In a prepared statement, Hutchinson, a member of the Senate Armed Services Committee, said he is leading the move to create a government-owned, contractor-operated vaccine production facility so the government will be involved in producing vaccines for threats like anthrax and smallpox.
A federal anti-terrorism commission led by Jim Gilmore, the governor of Virginia and head of the National Republican Party, recommended such a facility.
Plan On Drug Reimportation Dies
A conference committee negotiating the $75.9 billion Agriculture Appropriations Bill for 2002 struck a House amendment that would have allowed people to reimport FDA-approved prescription drugs from foreign countries.
¿We are pleased, particularly in this environment, that reimportation was not approved,¿ Sharon Cohen, vice president of health policy at BIO, told BioWorld Today. ¿There¿s no telling what could come over our borders.¿
Reimportation legislation was approved last fall as part of the fiscal year 2001 Agriculture Appropriations Bill and was signed by former President Bill Clinton. But Donna Shalala, Clinton¿s secretary of Health and Human Services, failed to implement the legislation because she could not demonstrate that it was safe or that it would reduce costs. (See BioWorld Today, Oct. 2, 2000, and Dec. 29, 2000.)
In the last year, several members of Congress have attempted to sell differing versions of the issue to their colleagues.
The $74.3 billion House version of the fiscal 2002 agriculture bill included an amendment introduced by Rep. Gil Gutknecht (R-N.M.) that would prohibit FDA money from being used to police the reimportation of U.S.-approved prescription drugs from other countries. The amendment allows reimportation by an ¿individual who is not in the business of reimporting prescription drugs,¿ as long as such products are not regulated or controlled substances. (See BioWorld Today, July 12, 2001, and Nov. 2, 2001.)
But early this month, the Senate passed a $73.9 billion agriculture bill that did not include a drug reimportation amendment.
Thursday¿s committee decision to cut the amendment simply means the issue is dead for the upcoming fiscal year.
Even Cohen admitted it¿s hard to say whether any issue is ever dead in Washington.
Rogan Wins Committee Support
BIO released a statement Friday in support of James Rogan, President George Bush¿s nominee as director of the U.S. Patent and Trademark Office. Rogan, a former House member from California, also served on the Judiciary Committee¿s Subcommittee on Courts, the Internet and Intellectual Property. The Senate Judiciary Committee recommended approval of Rogan.