American Medical Association calling for an end to direct-to-consumer drug advertising

The American Medical Association (AMA) has taken an interesting policy stance in an effort to promote affordable treatment options. In an interim meeting held November 17, 2015, the AMA voted to support a ban on direct consumer advertising of drugs and medical devices. The physicians believe that these advertisements are causing patients to push for more expensive treatments while cheaper, effective alternatives are available.

Consumer advertising

The U.S. is one of two countries in the world that permits direct consumer advertising of drugs, the other being New Zealand. According to the World Health Organization (WHO),  the practice became much more popular in 1997 after the FDA loosened the requirement for manufacturers to provide a list of side-effects in infomercials. Companies attempted to push for more advertising opportunities in Europe, but the European Union countries strongly opposed the section of new legislation that would allow companies to provide more information directly to patients through the internet and specialist publications.

A study published in 2003 compared prescribing decisions in the U.S. with decisions in Canada and how those decisions were impacted by consumer advertising. Patients were surveyed before primary care appointments on how much advertising they had been exposed to, while physicians were surveyed after their appointments to find out how many patients requested an advertised medicine and how many prescriptions were written in response to patient request. The survey also asked physicians to measure their confidence in the treatment choice and whether the physician would have prescribed the same drug to another patient with the same diagnosis. The study’s results indicated that those exposed to more advertising are more likely to request those medications, which leads to more prescriptions written even if the physicians are not confident about the treatment.

A long debate

Despite the fact that advertisements are overseen by the FDA for truth and accuracy, the practice has been debated for years.  In 2008, Time approached the topic after it received some scrutiny in a House of Representatives hearing. The article stated that drug ads often leave viewers confused about the information that they saw. This assertion was supported with notes from a New England Journal of Medicine article that pointed out the ease with which a medical device advertisement glossed over information that is still being debated by specialists. Time analyzed how ads are created, with an emphasis on the drug’s benefits at the beginning and end of a commercial when they are more likely to be remembered with side effect information squeezed in the middle. Ads often speed up the voice over when listing side effects, which caused viewers to be less likely to remember them when tested than for ads that maintained a constant voice over speed.

Why the opposition?

The AMA believes that skyrocketing drug prices are affecting physicians’ ability to properly care for patients, such as when there are limitations on their health insurance plans or out-of-pocket prices are unaffordable. The association points to marketing as one of the reasons for the increase in prices, with pharmaceutical companies spending billions of dollars to advertise their drugs in hopes that patients will request them specifically. The new policy urges federal limitations on anticompetitive behavior among pharmaceutical companies that try to sway business away from generic manufacturers, as well as patent reform. The AMA believes that transparency of prescription drug pricing will benefit patients and physicians.

Whistleblowers rake in heart-stopping $38M in cardiac device FCA settlements

Almost 500 hospitals have agreed to pay the United States over $250 million to resolve allegations that they violated the False Claims Act (FCA) (31 U.S.C. §3729 et seq.) by implanting cardiac devices in violation of Medicare coverage requirements. The Department of Justice announced the agreements, which involve 70 settlements and 457 hospitals spanning across 43 states, and represent one of the largest whistleblower suits and most significant FCA recoveries in the country. The settlements arose from a single lawsuit filed by two whistleblowers who have received a whopping $38 million under the FCA’s whistleblower provision.

Cardiac devices

The settlements involve the implantable cardioverter defibrillator (ICD), which is an electronic device that connects to the heart. The ICD detects and treats life-threatening heart rhythms, known as fibrillations, by delivering a shock to the heart to restore the heart’s normal rhythm. It is similar to an external defibrillator, but it is small enough to be implanted in a patient’s chest. Only certain patients who have specific clinical characteristics and risk factors qualify for Medicare coverage for an ICD.

Medicare coverage

A National Coverage Determination (NCD) governs whether the device, which costs approximately $25,000, will be covered by Medicare. CMS implemented the NCD based on clinical trials and guidance from various cardiac health care providers, professional cardiology organizations, and device manufacturers. According to the NCD, there should be a waiting period before ICDs are implanted in patients who recently suffered a heart attack or who had heart bypass surgery or angioplasty. The purpose of the waiting period is to allow the heart the opportunity to improve function on its own so that an ICD may not be required.

Qui tam lawsuit

The hospitals were alleged to have implanted ICDs from 2003 to 2010 during periods that were prohibited by the NCD. Most of the hospitals involved in the settlements were named in a qui tam lawsuit brought by two individuals under the whistleblower provision of the FCA (31 U.S.C. §3730), which allows private citizens to file lawsuits on behalf of the government for violations of the statute and to share in any resulting recovery.

FDA quietly lifts knowledge-based labeling requirement from the ‘intended use’ definition for drugs and devices

On September 25, 2015, the FDA issued a proposed rule ostensibly designed to merely clarify the circumstances in which a tobacco product “intended” for human consumption will be deemed subject to regulation as a drug, device, or a combination product.  On its face, the proposed rule only affects tobacco products. However, if one reads the preamble and the proposed regulations carefully, they will see that the FDA  is also quietly proposing the amendment of the drug and device “intended use” definitions at 21 C.F.R. §§201.128 (drugs) and 801.4 (devices) to: (1) eliminate the need for a manufacturer or distributor to label a drug or device for an off-label, or unapproved, use solely because it has knowledge that the product is being prescribed or used by a physician(s) for that off-label use; and (2) to ameliorate industry fears that the FDA may deem the off-label use by a physician(s) to be an unapproved use, potentially resulting in FDA action against the manufacturer or distributor.

The original “intended use” definitions for drugs and devices were issued in on February 13, 1976 (41 FR 6911). They state that to establish a product’s intended use, and thereby determine the FDA’s regulatory authority and appropriate labeling, the FDA is not limited by the manufacturer or distributor’s subjective claims of intent, but can also consider objective evidence, such as direct and circumstantial evidence. This objective intent may be shown by labeling claims, advertising matter, or oral and written statements by the manufacturer or distributors or their representatives. It may also be shown by circumstances in which the product is, with the knowledge of the manufacturer, distributor, or their representatives, offered and used for a purpose for which it is neither labeled or advertised. This objective intent definition will not be altered if the proposed rule is finalized.

The proposed rule, however, removes the following language from both 21 C.F.R. §§201.128 and 801.4, which has been present since 1976:

“But if a manufacturer knows, or has knowledge of facts that would give him notice, that a drug introduced into interstate commerce by him is to be used for conditions, purposes, or uses other than the ones for which he offers it, he is required to provide adequate labeling for such a drug which accords with such other uses to which the article is to be put.”

While the FDA has never enforced this so-called ‘knowledge’ provision, this long-overdue removal of the language should eliminate any lingering doubt in the minds of industry that providing FDA-approved on-label product use information to physicians that may be prescribing the product off-label will not subject the manufacturer or distributor to criminal or civil liability, or accusations that their labeling is inadequate.  As the FDA explicitly states on page 57757 of the proposed rule: “The Agency would not regard a firm as intending an unapproved new use for an approved or cleared medical product based solely on the firm’s knowledge that such product was being prescribed or used by doctors for such use [emphasis added].”

Firms, however, are not totally off the hook.  They should take note of the fact that the FDA deliberately used the word “solely.” Therefore, if something more than mere knowledge of off-label use by the physician is present, the FDA may still take action.


New hearing aid uses lasers, direct eardrum stimulation

Hearing aids have been around since the very end of the 1800s, but surely none of the first users imaged that the devices would eventually use lasers. On September 29, 2015, the FDA approved a new type of hearing aid for marketing that combines laser pulses and direct eardrum stimulation to amplify sound. The EarLens Contact Hearing Device™ (CHD) has received an indication for use in adults with mild to severe hearing impairment.

How does it work?

This device depends on two different parts working in unison. A tympanic membrane transducer (TMT) is placed on the eardrum (non-surgically) while an audio processor sits on the outer ear. The audio processor is connected to an ear tip containing a laser diode, which is placed into the ear canal. When the behind-the-ear (BTE) processor receives external sound waves, it converts them to low electronic signals that are sent to the ear tip. The signals are converted to pulses of light, which shine onto the TMT’s photodetector. The photodetector converts the light back into electronic signals and then transmits the sound vibrations onto the ear drum.

How is it different?

There are already multiple types of hearing aids. Some sit in the ear (ITE), some in the canal (ITC) and some behind the ear.  Older analog hearing aids simply amplified sounds, and some users struggled with them because all sounds were equally amplified by the device’s microphone. Some of these aids are programmable to hold separate settings for various environments, but they are not as sensitive to sounds as digital aids. Digital aids contain a chip that analyzes sounds based on the environment and user’s degree of hearing loss. The microphone amplifies sounds with an adjustment for volume and pitch, as well as feedback.

The EarLens, by contrast, is custom molded to the eardrum. The sounds are amplified by direct stimulation of the eardrum. The FDA believes that this is a new option for amplifying sounds over many frequencies.

Safety and effectiveness

The EarLens was studied over a four-month period for safety and effectiveness. The trials assessed residual hearing stability, amplification gain, and improved word recognition. Users’ ability to hear sentences in background noise with the device was compared to listening without any amplification. After a month of using the device, the 48 subjects experienced word recognition improvement by about a third. They also experienced a significant functional gain in the high frequency range. A maximum of 68 decibels was gained in the 9000-10,000 Hz range, which the FDA notes is not usually achieved with conventional hearing aids. There were some ear canal abrasions experienced, mainly due to the ear tip or forming the impressions. However, no serious adverse events were reported.

Who pays?

Medicare does not cover routine hearing exams or hearing aids. Part B will cover some diagnostic hearing exams if a doctor order these tests (20 percent of the Medicare-approved amount, along with the Part B deductible). Some Medicare Advantage plans may have some sort of hearing coverage. Only a few private insurance companies cover hearing aids, although three states (Arkansas, New Hampshire, and Rhode Island) require coverage for adults. This can be a problem for patients who suffer hearing loss, as prices can range up to thousands of dollars for one aid.

A House bill was introduced in March 2015 (H.R. 1653) proposing to repeal the Medicare hearing aid exclusion. After it was introduced, the Government Accountability Office (GAO) was instructed to study financial aid programs for hearing aids, as well as related examinations for patients suffering hearing loss.