A New Year will bring a new president, a new FDA chief, many new drug regulations, and, possibly, health insurance reform. Mindful of the ton of major drug brands that will go off-patent in 2009, drug companies have not rested in their lobbying efforts over generics and patent issues. They continue to spend millions urging government to do things in their favor.
In fact President Obama is already sitting down with lobbyists. He's scheduled 4,200 meetings (is that even possible?), many with healthcare interests. (Although, as BNET readers know, some lobbyists have been tied up on sushi dates in California.) Here's a look, per the AP, at a selection of companies and reports on what they spent their lobbying money on in Q3 of 2008:
- Pfizer, $3.1 million Pfizer lobbied on whether the federal government can negotiate price discounts for drugs bought under the Medicare program. It lobbied Congress on efforts to allow importation of cheaper prescription drugs from Canada and other foreign countries. Proponents say foreign competition would help drive down U.S. drug prices; domestic drugmakers [like Pfizer] argue imports would expose consumers to risky counterfeit products. The issue hasn't gained much traction in Congress so far, but that could change under the administration of President-elect Barack Obama.
- Teva, $570,000 Teva and the Generic Pharmaceutical Association lobbied the US Congress, the US Food and Drug Administration (FDA) and other US authorities on various issues although top of the agenda at present is the moving forward of biogeneric legislation, which is expected to make progress in 2009. Teva has also lobbied on issues relating to patents and product commercialization. The competition between ethical drug makers and their generic counterparts also includes the spending of vast sums of money and efforts in lobbying in the US. As part of this drive, The Generic Pharmaceutical Association spent $507,000 on lobbying in the third quarter, with the world's largest generics maker, Teva spending a further $570,000 alone,
- Merck, $1.1 million ... the Whitehouse Station, N.J.-based company opposed a proposal by House Democrats to let the government negotiate drug prices for seniors in Medicare. Currently, private health insurers negotiate drug prices with pharmaceutical companies and offer various plans to seniors. Merck lobbied for demonstration projects to assess how effective obesity management programs are and to support "congressional interest in obesity awareness efforts." Anti-obesity drugs have been one of the company's priority research areas for a few years, but in October it halted development of its lead candidate, taranabant, because of links to depression and other psychiatric problems. Merck's lobbyists opposed efforts that would allow importing cheaper prescription drugs from foreign countries such as Canada that put price controls on medicines. Proponents say they would help drive down U.S. drug prices, but domestic drugmakers argue imports would expose consumers to risky counterfeit products. The issue hasn't gained much traction in Congress so far, but that could change under the administration of President-elect Barack Obama.
- Bristol-Myers Squibb, $840,000 The New York-based company also lobbied Congress on a bill that would ban the use of a plastic-hardening chemical called bisphenol-A in children's food packaging. The chemical has been used to seal food containers, including baby formula. Bristol-Myers, the maker of Enfamil infant formula, lobbied to inform Congress that the materials used to line infant formula cans are safe. Bristol-Myers also lobbied to retain the current rebate levels companies get for drugs sold through the Medicare program and to extend a tax credit on research, according to the form filed Oct. 16 with the House clerk's officeThe company lobbied for increased awareness and funding to help pay for medicines in several areas where it sells products, including anti-clotting drugs to prevent strokes - it sells Plavix, the second best-selling drug in the world, as well as Coumadin - and drugs for AIDS (Atripla and Sustiva) and mental health disorders (Abilify for depression and schizophrenia).
- Wyeth, $757,000 The Madison, N.J.-based company lobbied on extending the State Children's Health Insurance Program, disclosing drugmaker payments to doctors, drugs rebates paid to the Medicaid program and government negotiation of prices paid for drugs for seniors under the Medicare program. Wyeth lobbied against efforts to allow the importation of cheaper prescription medicines from Canada and other foreign countries.
- Novartis, $1.4 million Novartis lobbied on bills designed to ensure the government has a sufficient stockpile of influenza vaccine in case of an outbreak, and that the government helps pay for vaccines for seniors, children and uninsured adults. The company makes flu vaccine, as well as vaccines against rabies, meningitis and several childhood illnesses. Novartis also lobbied on the Defense Department's budget and another bill involving the military's Tricare program, which insures about 9 million current and retired service members and dependents. The company, which makes two anti-rejection drugs, Neoral and Myfortic, lobbied to provide comprehensive coverage for immune-suppressing drugs for kidney transplant patients.
- GlaxoSmithKline, $2 million Glaxo lobbied on the budgets for the departments of Labor, Education and Health and Human Services, as well as related agencies, and on bills funding the state Children's Health Insurance Programs. It lobbied on legislation related to drug safety, drugmaker payments to doctors, vaccine supply programs and the law covering industry whistleblowers. The company is one of the few major makers of vaccines, with about two dozen on the market, including flu shots and several standard children's vaccines against diphtheria, pertussis, tetanus and rotavirus.
- Johnson & Johnson, $1.5 million The New Brunswick, N.J.-based company lobbied against legislation that would allow the U.S. to import cheaper prescription drugs from Canada and other foreign countries. Proponents said foreign competition would help drive down U.S. drug prices, but the domestic drug industry argues imports would expose consumers to risky counterfeit products.
- Sanofi-Aventis, $1.8 million The U.S. subsidiary lobbied on issues related to men's health, cancer awareness, diabetes care and treatment of life-threatening blood clots called deep vein thrombosis. Sanofi-Aventis makes multiple cancer drugs, insulin pens and injections. It also jointly markets, with Bristol-Myers Squibb Co. (nyse: BMY - news - people ), the anti-clotting pill Plavix, the world's No. 2-selling drug, and also sells and an injected drug called Lovenox for deep vein thrombosis. Sanofi-Aventis U.S. Inc. also lobbied on issues related to the Medicaid program and on a bill that would extend a research and development tax credit popular in the pharmaceutical industry.
- Novo Nordisk, $300,000 Novo Nordisk also lobbied on legislation, widely opposed by the pharmaceutical industry, to allow government negotiation of prices paid for drugs for seniors under the Medicare program. Company representatives also lobbied on drug imports, patient safety protection, patent reform, disclosing industry gifts and payments to doctors, and a bill to reduce health disparities among minorities.
- PhRMA, $5.4 million ... lobbied the federal government on legislation involving allowing generic versions of biologic drugs, reimportation of prescription drugs, and the budgets for the Food and Drug Administration and the Department of Health and Human Services. PhRMA opposed an effort in Congress to reform the U.S. patent system. High-tech companies support the bill that passed the House last year, saying it would cut down on frivolous patent-infringement lawsuits. But the pharmaceutical industry has argued it will weaken patent protections on drugs by reducing infringement penalties. The bill has stalled in the Senate and is not expected to pass this year.
- Amgen, $2.4 million The Thousand Oaks, Calif.-based company lobbied on legislation that would allow the Food and Drug Administration to approve generic copies of biotech drugs and on drug safety issues. (Amgen fears competition from generic biotech drugs.)
- Amylin, $540,000 Amylin Pharmaceuticals spent $540K on the generic biotech drug issue. While a system to approve generic pharmaceuticals has long been in place, no such pathway exists for quickly approving generic biotech drugs. This has been a major boon for biotech companies since they don't have to worry about patent expiration and generic competition the way pharmaceutical companies do. But with the Obama Administration looking to drastically cut healthcare costs, biotech's virtually generic competition-free golden age may be coming to a close. Drug prices were a major focus for both candidates in the election, and biotech drugs top the charts as some of the most expensive treatments available. Improving the approval process for generic copies of these drugs would be one way to cut those costs--an approach that the new administration will certainly consider.
- Genentech, $570,000 The South San Francisco, Calif.-based-based company lobbied on plans that would allow generic drug companies to make cheaper versions of biotech drugs, on a bill that would require drug companies to disclose spending on gifts to physicians, and on patent reform.
- Biotechnology Industry Organization, $1.9 million Genentech and Amgen are members. The group also has been at the forefront in the now stalled efforts to allow generic drug companies to make cheaper versions of biotech drugs. Currently, the Food and Drug Administration only has a system in place for approving generic versions of chemical-based drugs. Biotech drugs are made using living cells and are more complex.