Cost of medicine could increase

Brand-name drugmakers target generic prescriptions

June 17, 2008|By Jonathan D. Rockoff | Jonathan D. Rockoff,Sun reporter

WASHINGTON - 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.

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