Relationship between doctors, drug companies questioned as debate continues over prices

As the matter of prescription drug prices continues to generate debate, and some federal government action, one consumer advocate is warning the Food and Drug Administration (FDA) has loosened rules over interactions between physicians and pharmaceutical companies.

Health and Human Services Secretary Alex Azar announced May 8 that all television commercials for medications, often including the "ask your doctor" line, must include the list price of the drug.

However, it is unclear how this will affect the pockets of consumers, costs of insurance, and impact the wider health care system, given the complex network of players involved in pricing, the drug companies, pharmacy benefit managers (PBMs), insurance companies, health providers, including physicians, insurance companies,pharmacists and the consumer.

Dr. Michael Carome, an expert about drugs and medical devices at the consumer advocacy, Public Citizen, said drug companies and some doctors have always had a close relationship, and the "FDA has loosened the rules in some respects."

The FDA does not regulate doctors, and they are free to prescribe any medication for any condition, so-called off-label. It is illegal for drug companies to market a drug approved by the FDA for another purpose, but there are multiple reports of them doing so and facing civil and criminal fines.

The agency allows "drug companies to distribute scientific material, medical journals, anything about off-label use as long its truthful," Carome told FDA Reporter. "It may be misleading, and research funded by the companies, but still l truthful."

Carome, a veteran and former staff member at Walter Reed Medical Center, said drug companies want even more freedom to influence doctors.

"We have no doubt these types of promotional efforts influence prescribing; companies know what works, and it does have an impact on medical care," Carome said.

"Drugs most heavily promoted are the newest and most expensive, [they] drives up costs for patients, the health system, and insurers. Generic drug makers do not invest heavily [in marketing]'"

Drug companies spent billions of dollars trying to influence the prescribing behavior of physicians, he said, adding that "doctors often succumb to the new, equating this with innovation, but the older drugs are often just as good."

Although some high-profile cases of illegal attempts at influence are known, often the approach is more subtle, with expert sales people talking up medications, gifts, medical equipment, the use of "thought leaders," and speaking fees, Carome said, adding that research money also follows experimental drugs.

The open payments database, which tracks all payments, straight and in kind, to physicians from drug and medical device producers, has brought some transparency, Carome said.

From 2013 to the end of 2017, the total dollar value tracked was $8.1 billion. This does not include the 2018 amount.