Generics Seek New Prescription for Influence

Posted October 13, 2009 at 6:34pm

The generic drug industry, outmanned and outspent on the lobbying front compared to its name-brand counterparts, has been struggling to be heard on Capitol Hill throughout the health care debate.

Now, with the completion of Senate Finance Committee work Tuesday, generic companies and their allies are trying to raise their voices as Democratic House and Senate leaders begin the next phase in moving massive health care legislation through Congress.

Health care interests, both large and small, will focus on an array of provisions tucked into the bills that must now be melded by the leaders before the legislation is brought to the floor for a vote. The generic industry will be zeroing in on provisions adapted by key committees in both chambers that would shut it out of the biologic drug market for at least 12 years.

Brand-name manufacturers say they need that time to develop the innovative products, which are often made from living cells, and to recover their investments. But officials with generic companies say they should be allowed to enter the market within five to seven years, the same time frame that now applies to traditional chemical-based drugs.

They argue that if one of the goals of health care reform is to reduce medical costs, then lawmakers should allow lower-priced generics, or follow-on biologics, on the market as soon as possible.

“The current bill is not going to provide needed access to affordable life saving medicines,— said Kathleen Jaeger, president of the Generic Pharmaceutical Association, which represents 50 companies.

The generic drug companies, however, face an uphill fight.

Led by their powerful and well-connected industry association, the Pharmaceutical Research and Manufacturers of America, the brand-name drug companies have dispatched legions of lobbyists to Capitol Hill.

Early on, PhRMA also racked up bonus points with the White House and some key lawmakers by striking a deal in which the industry offered up concessions worth $80 billion over 10 years to help defray drug costs for seniors.

The generic drug industry did not participate in those negotiations, and the sector’s executives acknowledge they are at a disadvantage when it comes to lobbying Congress.

“This is the David vs. Goliath in terms of the pharmaceutical industry,— said Debra Barrett, senior vice president of government affairs for Teva Pharmaceuticals, the largest manufacturer of generic drugs.

“In the world of lobbying, it is breaking through the noise,— Barrett said. “When you have 100 lobbyists, you have a lot of noise.—

Robert Blendon, professor of health policy and political analysis at Harvard University, said the generic industry has increased its footprint in Washington in recent years. But he said the sector’s problem in the current health care debate is that much of the public has not been following or does not understand the biologic drugs issue. That gives more of an advantage to the brand-name drug industry with its formidable lobbying presence.

“When you don’t have easy public understanding,— Blendon said, “lobbying power really counts.—

A PhRMA spokeswoman said the company would not comment on its lobbying efforts against the generic companies. But the industry group cited a Duke University study that concluded that it will take 13 to 16 years for publicly traded companies developing these new drugs to break even.

“Fair data protection allows our companies to make the extensive investment necessary to develop cutting-edge medicines that allow American patients to live longer, healthier and more productive lives,— PhRMA senior vice president Ken Johnson said in a statement.

To get its message across to Congress, PhRMA has employed 27 in-house lobbyists and 42 outside firms, according to lobbying registrations. In the first six months of this year, it spent $13 million on lobbying, according to a CQ MoneyLine analysis of lobbying disclosure forms filed with the Senate.

The Biotechnology Industry Organization, another group lobbying for longer exclusivity, spent $3.7 million overall on lobbying in the first half of 2009. BIO has hired 22 outside lobbying firms, public filings show.

By contrast the Generic Pharmaceutical Association, with an in-house lobbying staff of two and six outside firms, has spent $1.1 million in the first six months of this year.

However, generic Teva, an Israeli company with U.S. headquarters based outside of Philadelphia, has doubled its lobbying team to six people in recent years. In the first half of this year, the company spent $1.79 million on federal lobbying, almost three times the amount it spent during the same time period in 2002.

The company also last year hired a public relations firm, Gibraltar Associates, to help spread its message.

Barrett came to Teva in 2006 armed with experience working on Capitol Hill for Members such as Sens. Chris Dodd (D-Conn.) and Charles Schumer (D-N.Y.). She also had lobbied at the Washington Group.

While Barrett said there are experienced people willing to lobby for generics, she acknowledged that many outside firms have been snapped up by brand-name companies.

For example, Amgen, the large California-based biotech firm that has been aggressively pushing for biologic drug exclusivity, has hired 32 outside firms including politically connected shops such as the Podesta Group and the Duberstein Group.

Amgen shelled out $6.1 million in lobbying in the first half of this year, according to lobbying reports. Its political action committee has also contributed $236,000 in contributions to federal candidates, more than 10 times the $22,000 that Teva’s PAC gave to candidates, according to CQ MoneyLine.

In a statement, Amgen said it had broad support for the current provision on biologic drugs. It refers to follow-on biologics as biosimilars.

“The need for a responsible pathway for the approval of biosimilars is not about Amgen,— the statement said. “Sixteen governors, the House and Senate committees with overwhelming bipartisan support and more than 100 local and national patient, academic and economic development organizations all recognize that this issue is about ensuring patient safety and preserving incentives for the development of much needed new medicines to treat serious illnesses such as cancer, Alzheimer’s and Parkinson’s.—

Companies such as Amgen also have influential backers in Congress where the House Energy and Commerce Committee and the Senate Health, Education, Labor and Pensions Committee approved the biologic provisions by wide margins.

The sponsor of the biologic provision in the House Energy and Commerce Committee was Rep. Anna Eshoo (D-Calif.), a close ally of Speaker Nancy Pelosi (D-Calif.), whose Silicon Valley district is home to numerous biotech firms.

Eshoo defended the 12 years of exclusivity for brand-name biologic drugs, saying that time period is necessary for companies to get such groundbreaking products ready for clinical trials.

“This isn’t just a number picked out of a hat,— she said. While Eshoo said she understands that the generic industry “wants to make more money, this is more about the science and the patients.—

However, the generic industry also has some high-placed political friends. President Barack Obama has said he wants to open the biologic drug market within seven years to help keep costs down. Rep. Henry Waxman (D-Calif.), the chairman of the Energy and Commerce Committee and a sharp critic of brand-name drug companies, has also vowed to keep up the fight to give generic companies earlier access to the biologic market.

Also championing the cause of the generics are consumer groups, organized labor, the seniors’ lobby AARP and other groups representing employers and benefit managers.

Mark Merritt, president of the Pharmaceutical Care Management Association, which represents pharmacy benefit managers, said many companies who are trying to lower drug costs want to see generic versions of biologic drugs on the market quicker.

“This lousy 12-year bill, which is a juicy giveaway to the biotech lobby goes against health care reform’s [goals to cut costs],— said Merritt, whose association is co-sponsoring a briefing today on whether the legislation is too tilted in favor of the brand-name drug industry.