Doctors’ Group Questions Generic Drugs’ Reliability

One of the nation’s largest groups of practicing physicians on Monday challenged the reliability of some generic drugs and condemned the spread of laws and policies that mandate their use as a means of holding down health-care costs.

The American Academy of Family Physicians asserted in a position paper that generics are not necessarily identical to brand-name drugs, and therefore should not be mandated in the case of certain high risk or elderly patients and certain conditions such as psychoses.

The announcement, made at the group’s annual meeting in Los Angeles, comes amid growing controversy over the reliability of generics. The interest was triggered this spring by incidents of corruption in the regulation of the booming generics industry.

The physicians’ position runs counter to that of the U.S. Food and Drug Administration, which must approve all generics before they can be sold. The FDA contends generics contain the same active ingredients as brand-name drugs and therefore in most cases have the same effects.

FDA Commissioner Frank Young on Monday defended the methods by which the agency scrutinizes generics. He cautioned against confusing the question of whether generic and brand-name drugs are equivalent with the question of which is appropriate in a particular case.

Young, in Los Angeles to tour an FDA lab, acknowledged in an interview that physicians and pharmacists might need to use caution in some cases in switching patients from a brand-name drug to a generic, or from one generic to another.

For example, Young said the agency is reviewing the comparability of brand-name and generic drugs used to treat convulsions. The FDA, he said, also intends to review drugs for diabetes and asthma--diseases for which some physicians have questioned the advisability of switching to generics.

Generic drugs are copies of brand-name drugs marketed under their official chemical names. Under current law, they may be marketed only after the original drug’s 17-year patent expires and the firm that developed it has had time to recoup its investment.

The family-physician group, representing 66,000 doctors and medical students, challenged the FDA’s method of measuring the so-called equivalence of a generic drug by studying the levels of the drug in the blood and urine of study subjects.

The group argued that just because two drugs are “bioequivalent”--that is, they are chemically comparable and reach similar levels in the blood and urine--does not necessarily mean they have the same therapeutic effect. For that reason, academy officials contended, a patient who is switched from a brand name to a generic drug may no longer benefit from the treatment or may experience unanticipated side effects.

“Our concern is that there needs to be a higher degree of recognition . . . and a higher degree of caution . . . that simply using generic drugs may not in all patients in all cases . . . lead to the anticipated therapeutic effect,” said Dr. Robert Graham, executive vice president of the physician group.

Paper Condemned

The Generic Pharmaceutical Industry Assn. on Monday condemned the position paper:

“The text of the report simply restates the discredited arguments against generic drugs that brand-name companies periodically recycle in their promotional campaigns to prevent competition and the lowering of prescription-drug prices,” the group said.

The American Pharmaceutical Assn., a national pharmacists’ group, also questioned some of assertions made in the family physicians’ paper.

“There are quality generic products,” said Arthur Kibbe, director of scientific affairs. “ . . . We think that the decisions about health care for patients should be made by the physician, patient and pharmacist working together to get the best therapeutic effect.”

Ten states, not including California, have enacted laws requiring pharmacists to dispense generic drugs unless the prescribing physician specifically states on the prescription form that generics should not be substituted for the brand-name drug.

In addition, approximately 25 states, including California, limit the level at which they will reimburse pharmacists for prescriptions filled under Medicaid programs for the poor. Those limits create a powerful economic incentive for dispensing a generic.

In California, pharmacists may (but are not required to) substitute generics in cases in which the physician does not specifically bar it. Under the Medi-Cal program, a physician insisting on a brand-name drug usually must submit a written request for state review.

In addition, some hospitals, health maintenance organizations and third-party payers strongly encourage the dispensing of generics, which carry prices that are often dramatically lower than that of their brand-name counterparts.

The family physician group recommended against mandatory substitution in the case of certain patients, diseases or drugs. Those include patients over age 74 and diseases that are “difficult to stabilize.”

The diseases cited by the group include depression, asthma, congestive heart failure, diabetes mellitus, cardiac problems and psychoses. Two classes of drugs were cited: anti-psychotics and “loop diuretics,” which remove excess water from the body.

Responding to the position paper, Young defended the agency’s methods for comparing generic and brand-name drugs. He said studies for bioequivalence remain “the best proxy we’ve got at this time” for gauging so-called therapeutic equivalence.

Young acknowledged that problems can conceivably arise if a patient is switched from a brand-name to a generic or vice versa. Under the law, the FDA allows a certain degree of variation in potency, usually about 20%.

Young emphasized that his agency is eager to work with groups such as the family physicians to investigate reports of problems caused by generics. He encouraged physicians with reliable data suggesting differences between generics and brand-name drugs to speak to the agency.