The August 31 resignation of a top Food and Drug Administration official illustrates just how much the FDA attitude toward emergency contraception has changed.
Seven years ago the FDA asked a retired pharmaceutical executive, Roderick Mackenzie, to submit a drug application for an emergency contraceptive. He founded a company called Gynetics and put together a pill, based on a generally accepted combination of birth control hormone pills, that could prevent pregnancy when taken within 72 hours of unprotected sex.
Mackenzie submitted this pill, Preven, for approval, in 1998. The FDA – which, after all, had practically commissioned this drug – fast-tracked it to be dispensed by prescription.
But the women who need the pill most are the very ones who would find it daunting to get a prescription, so many lobbied for Preven to be available as an over-the-counter drug. Among them was Princeton University’s James Trussell, a population scientist who advocates the worldwide availability of birth control.
Trussell featured Preven on his Emergency Contraception website (www.not-2-late.com), published in four languages including Arabic. Before Preven, he listed the various recipes or "morning after" remedies (such as 40 small progestin pills). After Preven he put up a database of its national and global providers. (Emergency contraception or EC is not the same as the controversial abortion drug, RU486).
Then Preven was replaced by a drug called Plan B, made by Barr Laboratories, and Gynetics closed its Franklin Corner Road office. Barr Laboratories applied for over-the-counter sales on the grounds that a more easily available drug would prevent many of the estimated 3 million unplanned pregnancies in the United States and thus reduce the number of abortions. Trussell was a member of the expert committee of scientists, appointed by the FDA, who overwhelmingly approved the OTC application in December, 2003.
But the FDA’s attitude toward emergency contraception had changed. The application process dragged on until, finally, Barr Labs offered to limit sales to women older than 16.
The new FDA Commissioner, Lester Crawford, was confirmed by the Senate this summer only after he promised to make a final decision on this matter by September 1. In the last week of August Crawford overruled the FDA scientists’ recommendations and postponed, indefinitely, the drug’s over-the-counter release.
Noting that the FDA had no experience with enforcing a drug with an age limit, Crawford wrote that he also wants the FDA to consider whether the OTC drug and the prescription drug could be in the same package. He promised to expedite the studies and shortened the public comment period from 90 days to 60 days.
Susan Wood, director of the FDA’s Office of Women’s Health for five years, resigned on August 31 to protest what she predicts will be an additional two-year delay. In a memo to her colleagues she wrote, "I have spent the last 15 years working to ensure that science informs good health policy decisions. I can no longer serve as staff when scientific and clinical evidence, fully evaluated and recommended for approval by the professional staff here, has been overruled."
Mackenzie could not be reached for comment, but Trussell, who was on his way back from a meeting in Cape Town, E-mailed this message: "Susan Wood is hardly the only FDA employee disgusted by the FDA’s handling of the Plan B applications, as I know from my colleagues there. But few can afford to resign, at least immediately. I am humbled by her principled stand."
"Morale, especially in the two most directly affected divisions (Reproductive Health Drugs and OTC) is very low, for the obvious reasons stated by Susan in her letter of resignation: on this issue, for the first time, the FDA allowed politics to trump science," wrote Trussell. He predicts that the FDA’s best scientists will find new jobs. "For the best of them, that will not be hard. So the most insidious effect will be ultimately to deplete the agency of its best minds and managers and leaders. "
New in Town
StaticPaint, 11 Deer Park Drive, Suite 102B, Monmouth Junction 08852. Joseph Kaye, founder. 732-274-0001; fax, 732-438-9152. Home page: www.antistaticindustries.com
StaticPaint, a specialty manufacturer of paints and coatings for major American computer companies, moved from Hackensack in July to 11 Deer Park in Monmouth Junction. Joseph Kaye, a mechanical engineer and founder of StaticPaint, established its parent company, Anti-Static Industries, 20 years ago.
StaticPaint paints and coatings prevent damaging static electricity from developing around computer facilities. Kaye, who lives in Monroe Township, moved the company to Princeton after the Hackensack location he was leasing was condemned.
Charles Littlewood of Littlewood’s Office Systems has joined with Mercadien Technologies and moved from Whitehorse Hamilton Square Road to Mercadien’s office on Quakerbridge Road. The two companies have merged, says Blase E. Salvatore, president of Mercadien Technologies.
"We have, as part of our strategic plan, been looking for a group of professionals who share our values, commitment, and dedication to increasing clients’ profitability. We have found that philosophy in Littlewood. Furthermore, we are now able to provide the Littlewood’s Office Systems clients with additional services," said Salvatore in a prepared statement.
Charles "Chuck" Littlewood graduated from the RCA Computer School, sold large capital equipment to the metals industry, was a national sales manager of GTE’s former electrical products manufacturer, and has sold to computer companies and other original equipment manufacturer (OEM) industry markets.
After Littlewood’s Office Systems moved to computer technology in 1984, it focused on computing and networking for small businesses, serving as an MIS support team as well as consultant. Though it focused on smaller businesses, it also had global companies as its clients.
Mercadien Technologies has a similar aim, helping its clients maximize technology investments and concentrate on managing their business. It is part of the Mercadien Group Company, which also includes Mercadien Consulting, Mercadien Asset Management, Mercadien Outsourcing, the Mercadien Foundation, and Mercadien Securities.
Mercadien Technologies, 3625 Quakerbridge Road, Box 7648, Princeton 08543-7648. Blaise Salvatore, president. 609-689-2336; fax, 609-689-9720. Home page: www.mercadien.com
Zemlock Tax Advisory Group, 29 Emmons Drive, Suite A 30, Princeton 08540. Jordan L. Zemlock LUTCF, vice president. 609-514-5333; fax, 609-514-5339.
Jordan Zemlock has opened Zemlock Tax Advisory Group at 29 Emmons Drive, providing tax assistance for both individuals and business.
John Kirk and Marshall Calman opened a franchise office of a business coaching firm, Action International, at 100 Overlook. Kirk is transferring his practice, and Calman has been practicing in Mercer County.
Action coaches work with their clients in five key areas – sales, marketing and advertising, team building and recruitment, systems and business development, and customer service.
In addition to coaching services, Kirk and Calman expect to offer workshops. To introduce themselves to the community, they currently offer a business diagnostic consultation, which usually costs $345, for free.
Calman has an electrical engineering degree from Roger Williams University, Class of 1980, and an MBA from Fairleigh Dickinson. He had been vice president and general manager of the professional services division at Agilent and North American General Manager at Hewlett-Packard.
"It’s an exciting opportunity for me. I’ve always been passionate about helping individual business owners find solutions to the challenges inherent in running a successful enterprise," says Kirk. With a degree in criminal justice from the University of Delaware and a law degree from Widener, he practiced law for 25 years. "What the Action system has taught me is that it’s not enough to make your business profitable – your business also has to be fun."
Photon Technology International (PHTO), 300 Birmingham Road, Box 272, Birmingham 08011. Charles Marianik, president and CEO. 609-894-4420; fax, 609-894-1579. www.pti-nj.com
Photon Technology International moved from 4,000 square feet at 1009Lenox Drive to its own 9,600 square-foot building in Pemberton. "Wefound a better headquarters, and bought the building," says RosemaryMarianik, wife of founder Charles Marianik. Their son also works atthis office.
Founded in 1983, the firm manufactures, designs, and supports electro-optical components, subcomponents, and systems. It went public on NASDAQ in 1987 but has been delisted for 10 years and has just over 100 shareholders, she says. Princeton-based Edison Venture Fund was a primary investor.
Population Resource Center, 15 Roszel Road, Princeton 08540. Jane S. DeLung, president. 609-452-2822; fax, 609-452-0010. Home page:www.prcdc.org
The demographic research organization, previously headquartered at 15 Roszel Road, has consolidated its operations at its office at 1725 K Street NW, Suite 1102, Washington DC 20006. New phone is 202-467-5030.The center bridges demographic/social science research communities and policy makers on state, national, and international levels.
Phoebe G. Williams, 54, on September 1. She had taught preschool atthe Stuart Country Day School of the Sacred Heart.