Personalized Meddling

© Stephen Voss

In the frigid weeks of the US Congressional winter recess, the halls of government buildings around Capitol Hill are empty and quiet. But things are far from quiet for Frankie Trull, a biotechnology lobbyist. With the changing of the Congressional guard following the 2008 election comes a changing of the staff members that liaise with Trull's Washington, DC-based boutique firm, Policy Directions. This means a whole new set of people she has to convince of the merits of biotech.

In many ways, "lobbyist" has become something of a bad word, thanks to plenty of negative media coverage. It is not something one would immediately associate with biotech. Pharma, certainly so—together, the top 10 pharmaceutical companies doled out at least $70 million in 2008 alone on lobbying on the Hill.

But biotech trade organizations like the Massachusetts Biotechnology Council and the Biotechnology Industry Organization (BIO) are also powerful lobbyists on behalf of their member companies. And even smaller companies may be getting the hint that government relations should be part of their public relations strategies. Since 2001, BayBio, a Northern California biotech trade association that lobbies, has seen membership grow by at least 20% per year, according to Matt Gardner, president and CEO. Of the 450 current member companies, the average company is made up of fewer than 60 employees. "What we're seeing is an increasing number of early-stage companies participating in the process as they realize that the government is likely to be supportive, but might not be sure how to prioritize support mechanisms," says Gardner.

Even under normal circumstances, for individual biotech companies dealing with the complicated processes of bringing new compounds and products through trials, FDA approvals, and regulatory assessments, lobbyists are the one link between lab and lawmaker. With a better understanding of the ins and outs of the process, lawmakers are more likely to support bills that encourage, rather than stifle, biotech research and development.

"The biotech industry deals with an ongoing basic education challenge: that our industry is not well-understood," says Gardner. "The science behind biotech is not well understood—the process of going through basic research to clinical trials to successfully delivering a product to patients worldwide. It's incredibly complicated, it takes a long time, and we have to show that process to elected leaders."

In 2000, Trull's firm was engaged by a New Jersey biotech called Anthra (which has since been sold and disbanded) that had a compound designed to treat bladder cancer which had been voted against, by a count of 14-0, by an FDA advisory panel. Trull's team determined that not one member of the advisory panel had expertise in the subject matter. They took the issue to a New Jersey member of Congress, who then brought up the issue with the FDA. The federal agency agreed with the criticism, and added a knowledgeable person to the panel. The product was reconsidered and approved for market. Often, "technology gets ahead of the regulatory pathways," says Trull. "The FDA is always confronted with these kinds of challenges, and this is where lobbying really matters," she adds.

During the first weeks of 2009, Trull's seven-person lobbying team has been busy compiling analysis reports for each of Policy Directions' 25 or so current biotech and biomedical research clients, strategizing on how to confront bills and issues throughout the upcoming Congressional calendar year. Trull is expecting her year to be taken up by issues including legislation on genetically modified foods, federal drug reimbursement and generics policies, and the new administration's decision regarding stem cell research.

In an average week, Trull spends most of her days on the Hill, meeting with staff members in the health, agriculture, and energy committees. But as she clears security through the Congressional buildings, greeting by name the security guards and staff members passing by, her chic pantsuit and dark Jackie Onassis sunglasses give her the air of a well-connected socialite rather than hardnosed lobbyist.

"A lobbyist opens doors to meet the right people and establish the right relationships," says a prominent Congressional staff member who often deals with issues relating to biotech, and who asked to remain anonymous since he was violating procedure by speaking to a member of the press. Lobbyists provide information to staffers, he adds, who have more time than the representatives themselves to learn how legislation is likely to affect the research sector. "My job is to get into the minutia" of scientific issues and educate the committee members, he says. "When I have a question and I want a straight answer, I often call up a lobbyist that I trust."

Once hired, lobbyists meet with the company's local Congressional representative, and other representatives who might be sympathetic to the company's cause. They meet with staffers and often help them write legislation that supports the company's research, whether in support of transgenic plants or certain research technology; they can bring in CEOs to testify in relevant policy hearings; they can also keep track of patent laws. "These CEOs understand that if anything happens to their patents they're in deep trouble," says Jeffrey Taylor, a biotech lobbyist and senior vice president of International Government Relations, a lobbying group in Washington, DC.

Lobbyists can also find extra cash for biotechs in unlikely places. The Department of Defense, the Department of Energy, and the Department of Veterans Affairs all offer grants that might apply to biotech research. Congress designates how much money goes to each agency, and can recommend how much money to designate to individual projects. "Companies that don't hire [lobbyists] wonder why their competitors are getting all the money," says Trull.

Above all, lobbyists keep your cause in the lawmaker's ear. "All of this is to put you on the radar screen just in case you have to ask member of congress to intercede," says Taylor.

Several bills that Trull fought hard for hang framed on the walls of her Connecticut Avenue office. She got her first taste of lobbying when in the late 1970s she worked for Tufts University president Jean Mayer, garnering support from six New England governors and Congressional members to get state and federal funding to establish the Cummings School of Veterinary Medicine in 1978. Soon after, Trull started the Foundation for Biomedical Research (FBR), an organization that advocates the responsible use of animals in biomedical research. She still presides over and lobbies for FBR as president of another policy group, the National Association for Biomedical Research. FBR's most recent slogan, "Animal research saves animals, too," graced billboards along the Pennsylvania turnpike with a picture of none other than Trull's cat, Pookie.

Trull knows which Congress members have a special interest in breast cancer. She knows who has osteoporosis, or whose child has juvenile diabetes. All this information helps her target which representatives will be most sympathetic to her client's needs and goals. But she also knows which representatives will be miffed if they see her talking to someone on the other side of the aisle. In many ways it's not unlike navigating a mire of high school cliques. "[The] reason to hire Washington representation is because [biotechs] need someone to interpret what the hell's going on." Joining a large trade association like BIO or BayBio can help, says Trull, but those organizations represent thousands of biotech companies at a very broad level.

Of course, for start-ups operating solely on venture capital money, investing the baseline average of $10,000 a month to retain a lobbying firm is hard to justify, says Taylor. But with drastic changes in Congressional seats in the last election, the need may be greatest. "In the upcoming 111th Congress, it will be a very tough road for biotech companies," says Trull. "This is not to say that biotechs should run for cover, but they need to get in there and be heard early, and be heard often."