Healthy Skepticism Library item: 13811

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Publication type: news

Rockoff JD.
Cost of medicine could increase: Brand-name drugmakers target generic prescriptions
Baltimore Sun 2007 Jun 17
http://www.baltimoresun.com/news/health/bal-te.generic17jun17,0,6222587.story?track=rss

Full text:

Patients in Maryland and other states could face higher costs and delays getting prescriptions filled if a new push by major drugmakers to curb sales of generic drugs wins out, according to health officials and pharmacy specialists.

Large pharmaceutical companies have been waging war against inexpensive generic drugs for years at the national level. Now they are taking their fight to the states, promoting proposals that would mean pharmacists could no longer automatically replace certain brand-name drugs with no-name counterparts.

The state legislation could result in long delays filling prescriptions at the local pharmacy and undermine a key effort to restrain health care costs, opponents and independent specialists say.

Measures favorable to the major drug companies have been considered by 27 states and approved by two – Utah and Tennessee – over the past year, according to the National Association of Chain Drug Stores, which opposes the changes.

“It’s putting a fix to a problem that doesn’t exist,” said Lawrence M. Brown, director of the Center for Medication Therapy Management at the University of Tennessee Health Science Center.

By law, only the federal Food and Drug Administration can certify that a generic drug is safe enough to take the place of one with a brand name. Once that happens, states can give local pharmacists the power to substitute a lower-priced generic drug when a patient presents a prescription, unless the prescribing doctor orders the brand-name medicine. Nearly all states give pharmacists that option or require them to make the switch.

Generic substitution is a pillar of efforts to hold down health care spending, with studies estimating yearly savings of as much as $20 billion. The FDA has said repeatedly that generic drugs are safe and effective, and that brand-name drugs and their generic substitutes are equivalent and have the same effect on patients. But big drug companies say the common practice of substituting generics can cause harm. Even slight changes in formulation or manufacturing can cause side effects, they say.

The legislation being pushed at the state level would make the exchange more difficult by requiring pharmacists to inform doctors or get their permission before substituting a generic version of the drug.

“For most patients, it isn’t a problem, but for select patients it can be,” said Laureen Cassidy, a spokeswoman for Abbott Laboratories. She said Abbott’s promotion of the legislation was “limited,” but it does back the measures and hopes that the debate surrounding them will increase awareness of the need to tailor treatment to individual patients.

The industry-backed legislation began appearing in scattered statehouses last year and is picking up steam this year. While some proposals apply to any kind of prescription drug, most take aim at particular classes of medicines, such as drugs to suppress a patient’s immune system after a transplant, for example, or to curb epileptic seizures.

Opponents say the fight over generic epilepsy drugs, the most common subject of legislation, is typical of the drug industry’s statehouse campaign.

“When you get down to the state level, folks are not versed in FDA matters so it’s easy to confuse and fog the issues,” said Kathleen D. Jaeger, president of the Generic Pharmaceutical Association, an industry group fighting the legislative push.

Three brand-name epilepsy drugs – Depakote made by Abbott, Lamictal by GlaxoSmithKline and Topamax by Ortho-McNeil-Janssen Pharmaceuticals – that earn more than $5 billion a year in sales are scheduled to lose patent protections this year, according to the 2007 annual reports of their manufacturers.

Bills that would restrict generic sales have come up for debate in 21 states this year, and Utah passed a law, according to the chain drugstores association.

Maryland’s General Assembly considered two bills during the past session.

“I, for one, don’t like generic anything. They say it’s the same, but it’s not the same,” said Del. Barbara Robinson, a Baltimore Democrat who sponsored one of the Maryland proposals.

The Maryland Board of Pharmacy, a state agency, fought both measures, arguing that they would be needlessly difficult for pharmacists to implement. Brown, at the University of Tennessee, said that has been the case for many pharmacists in Tennessee, which passed a law last year ordering them to inform physicians before switching between generic and brand-name epilepsy drugs.

Nevertheless, Robinson said she will probably try again next year.

Del. Joseline Pena-Melnyk, a Democrat who represents Anne Arundel and Prince George’s counties and wrote the other bill, did not return calls for comment.

Robinson said she didn’t get any prodding from industry to introduce her measure. Legislators in four other states, however, said they proposed bills restricting epilepsy drug exchanges this year at the prompting of the drug industry or organizations supported by pharmaceutical companies.

Carol Pitts, a Republican state representative in South Dakota, said she grew concerned about pharmacists substituting drugs while at a January 2007 conference for female state legislators held at Marco Island, Fla. “I had not heard of that concept being talked about, but it made a lot of sense,” said the dietitian.

The conference was sponsored by Women in Government, a nonprofit that receives an undisclosed amount of its $2.5 million yearly budget from Abbott, GlaxoSmithKline, Ortho-McNeil-Janssen’s parent and other pharmaceutical companies. The organization has given several presentations on epilepsy treatment to raise awareness among legislators and protect patients, a spokeswoman said.

An Epilepsy Foundation official, Alexandra K. Finucane, vice president of legal and government affairs, helped give the presentation that Pitts attended. Back home, Pitts got help drafting a bill from an Epilepsy Foundation lobbyist, Pitts and the lobbyist said.

Several industry officials sit on the foundation’s board, and 10 percent of its $20 million budget comes from contributions by pharmaceutical companies, including epilepsy drugmakers, officials said.

Eric R. Hargis, the group’s president, said the donations support fundraising. Hargis said the legislative push was prompted by complaints from epilepsy patients whose pharmacists didn’t say their drug was being exchanged for another or presented the switch as a cheap, harmless and easy choice. Then the patients suffered seizures that risked their health and had serious consequences, such as losing their driving privileges.

Hargis emphasized that the foundation’s model legislation would also require pharmacists to get consent for switching between generic drugs, and he said the group is pursuing other steps, such as urging the FDA to assess the interchangeability of brand-name and generic epilepsy drugs.

Industry efforts to limit sales of generic drugs stem from the 1984 federal law that authorized the cheaper copies. Over the years, major drugmakers have filed patent infringement suits that delay sales of generics and have paid generic drugmakers to refrain from developing a competing drug.

“Now we’re morphing into going to states,” said Frank Palumbo, executive director of the Center on Drugs and Public Policy at the University of Maryland’s School of Pharmacy.