OPINION: Making Generic Drugs Hard to Get, A Greedy Grab by Drug Companies

By State Senator Roy Dyson (D-29th)

One of the few breaks Marylanders get from our health care system is easy access to generic drugs. The substitution of generic drugs for higher priced brand name drugs saves consumers as much as $20 billion every year.

It should be emphasized that before a generic drug is considered safe to take the place of the brand name drug, it must be certified as safe by the federal Food and Drug Administration - FDA. Once it is certified as safe by the FDA, the states can enact law to give local pharmacists the authority to substitute a lower priced generic drug. The FDA has stressed repeatedly that generic drugs are safe and effective and that they are equivalent to the brand name drug and have the same effect on patients.

In Maryland, as in most states, the law provides that unless a brand name drug is specifically ordered by the prescribing doctor, pharmacists may substitute the generic drug version.

Everyone appears to be happy with the arrangement, except the pharmaceutical industry because generic drug substitution cuts into its profit. For years, drug manufacturers have lobbied Congress and state legislatures to approve laws to make it more difficult to dispense generic drugs. The proposed legislation pushed by drug manufacturers requires pharmacists to request permission from the prescribing physician to substitute the generic drug.

The 2008 Maryland General Assembly rejected this proposed law. However, Utah and Tennessee have approved the legislation. Indeed, passage of the legislation makes the drug manufacturers happy because it delays and makes the substitution of generic drugs inconvenient.

It takes up the pharmacists' time to contact the prescribing doctor for permission to substitute the generic drug. It takes time from the doctors' busy day to approve the substitution. And it causes unnecessary delay for the customer. Let's face it, the legislation pushed by the drug manufacturers discourages the automatic dispensing of generic drug.

As it always does, the drug manufacturing lobby points out the huge cost manufacturers must bear for research and development of new drugs and getting them to market. What they do not point out is the fact that these costs are usually recouped within the first year the drug goes on the market. It should also be emphasized that when brand name drugs come on the market, they have patent restrictions for several years. Generic drug substitutions are prohibited until the patent expires.

Three brand name drugs for epilepsy - Depakote, Lamictal and Topamax have patents that are due to expire this year. These three drugs earn for their manufacturers $5 billion a year in sales. That's a big loss for the drug manufacturers and a big savings for consumers when generic drugs are substituted. It's no wonder that the manufacturers want new laws to slow down, delay and discourage generic drug substitution.

The delay tactic legislation is opposed by the Maryland Board of Pharmacy and the National Association of Chain Drug Stores. Lawrence Brown, director of the Center for Medication Therapy Management at the University of Tennessee, said the legislation "puts a fix to a problem that doesn't exist."

As the cost of gas, food, home heating and medical care skyrocket, we do not need a law that will cause the price of prescription drugs to increase any faster than they already increase.

If this delay tactic bill is introduced in the upcoming 2009 General Assembly session, be assured that I will oppose it.

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