I was shocked to see media stories saying DTC may expand to cover off label use. What! This erroneous idea came from an FDA open meeting held 11/16 to discuss off label use based on court cases allowing drug companies the right to discuss them. FDA has been under pressure on first amendment grounds to liberalize their restrictions on drug companies educating doctors and other learned players on off label studies.

As far as I know no one at FDA is seriously thinking of allowing drug companies to advertise off label use to the public through DTC. I know we are in an era of fake news but seriously folks. FDA goes nuts when the background music is too loud on DTC ads. Does anyone think they will allow drug companies to tout off label uses to consumers? No, they will not. Not even under free marketer Trump

The whole debate over off label is because courts have ruled drug companies can use commercial free speech to discuss studies reflecting off label uses. FDA is trying to figure out how to deal with the first amendment in regulating such uses. They have been strictly using approved label claims as the standard but drug companies want the right to tell the medical world about legitimate off label studies.

I do not think drug companies expect to carry this free speech argument to DTC. All they want is to be able to do is discuss such uses with medical professionals who would want to know that information. Can a detail rep tell a doctor about a study involving off label use? Can a drug company tout such off label uses in discussions with stock analysts? FDA has been quick to pounce on drug companies promoting off label studies to anyone. They fear misinterpretation and incorrect use. They might be justified in their concerns but also need to allow business speech that is fact based even if not yet approved in the label.

The lay press thinks that FDA might open the floodgates of off label use in DTC. A publication as reputable as Consumer Reports had a story 11/9/16 titled “FDA Considers Allowing Drug Ads for Unapproved Treatments.” I am not sure why Consumer Reports made the leap from possibly loosening the regulations for discussions with doctors all the way to DTC. That story seemed to be picked up by many news organizations who said drug ads may increase because of off label uses.

I think the FDA will take years to study this issue and not do more than the courts push them to do. They are just figuring out how drug companies can use the Internet about 20 years late. They are worried consumers will get confused figuring out how to click on the fair balance. So, I do not think off label use is on their list of DTC to do projects, not for a decade or two.

Trying to be objective about Obamacare seems to be as difficult as with every other major policy issue these days. The newspaper headlines from the media are saying thousands of people will die if Obamacare is repealed. The Washington Post in a January 23 story cited estimates by medical professors who estimate the number at 44,000 annually. Bernie Sanders said 36,000 will die. These numbers assume no replacement plan which no Republican is advocating.

I looked at some statistics to see whether Obamacare is as good or as bad as critics say. First Obamacare definitely added millions of people to the insured category. That is a fact not disputed. The HHS says 20 million people have been added to the insured rolls since 2010. About 12 million are in the exchanges and the rest are covered by Medicaid expansion. We also see several million children under 26 kept on their parents’ plan.

The issue to debate is did we add enrollees cost effectively. Are we all paying more to insure these 20 million than we should? Republicans say there are better ways to get people coverage. Did costs rise? Yes, they did for Obamacare enrollees and those covered by employers as well. In 2008 according to the Kaiser Family Foundation the average family plan cost employers $12,680 with $3,354 borne by employees. In 2016 costs were $18,142 with employees picking up $5,277. Supporters of Obamacare say costs were rising before it was implemented so this rise is not from the Obamacare provisions.

That is not the only problem. Deductibles have risen dramatically. In 2008, only 16% of employer plans had deductibles of $1,000 or more. In 2016, 51% of employees covered had $1,000 or more in deductibles. On the Obamacare exchanges the situation is much worse. Deductibles vary by type of plan chosen with more expensive premiums providing lower deductibles. The popular Bronze plans average more than $5,000 in deductibles. It is probably fair to attribute these huge deductibles partially to the coverage mandates.

We are also seeing many state exchanges showing huge increases in premiums with the average being 15% in 2016. Many families are paying well over $10,000 in premiums and deductibles. For them Obamacare essentially just covers them for a catastrophic illness. It is true they get a free prevention exam and some other free diagnostic tests but that is not much for their $10,000.

Supporters of Obamacare say having 20 million more people covered is a societal benefit worth paying for by all of us. Maybe it is, but just maybe we are all paying more than we need to if we had a different approach. The Republicans say they can provide better coverage at lower cost. They think free market insurance competition and giving the states more control over budgets can lower cost. They also think that more consumer responsibility for spending decisions will make patients more aware of cost and provide pushback on healthcare prices.

What is very clear is that Mr. Obama’s promise of lowering premiums for every family was not achieved. In 2008 he promised the average family will save up to $2,500 a year. Many markets now only have one insurer willing to provide coverage. Clearly this reduced competition is not helping lower premium rates. While more people are covered today than pre-Obamacare, the jury is out on whether we are better off. That depends on who you are. Anyone with a pre-existing condition is likely better off. Those of us who had employer coverage before are likely not better off today because we are subsidizing insurance companies mandated to cover pre-existing conditions.

Democrats find many examples of the poor or people previously denied coverage who now have access to care. They tout these as reasons to keep Obamacare. Analyzing success, however, must also include the effects on everyone who is asked to pay for it. My guess is we have better alternatives that will provide coverage for less. That does not mean all people currently insured and subsidized will be better off under a new Republican plan. What is clear from Obamacare is insuring people already sick is very expensive and that healthy people do not sign up in high enough numbers to subsidize those folks.

As a compassionate society, we should not let people lose their life savings or get no care because they get sick. That does not mean we cannot create a much more targeted and affordable plan to do that. The proof will be in the details from the replacement plans proposed. Level headed analysis rather than hyperbole is what is needed in Congress but we do not seem to be in the political mood to do that. Keeping an unaffordable plan is not the answer the American people are seeking.

DTC will be much more important in the new health care era post Obamacare. This is not just for drug companies but for all health care goods and services. The Trumpcare plan will be shifting more decisions on health care to consumers based on free market competition. Americans will be given greater control over spending a pot of dollars allocated to them by government. Although we have not seen a final replacement plan we do know it will likely contain health savings accounts, tax credits, wider choices for insurance coverage, and some minimum affordable coverage for people with pre-existing conditions.

Americans will be encouraged to shop for health care like they do for all other products they buy. Yes I know the critics of free markets say health care decisions are different from other types of products and more important than choosing a dishwasher or cell phone. What consumers will do is give health care decisions much more consideration. Consumers probably spend a lot more time shopping for a car than for a heart surgeon. To evaluate health care decisions they will need transparency on prices and good information on pros and cons of their choices.

Health care information on products and services will become a boom industry. Rating services will spring up that tell consumers what health care services should cost and provide reviews on providers price/value. A free market will rely even more on advertising to pitch and justify services and this is where DTC will grow. We already have hospitals and physician advertising to consumers. What will change is a much more explicit price/value oriented advertising approach. As consumers are given more control over their limited health care spending, they will need more convincing on where to spend those scarce funds.

In today’s someone else pays system, we do not usually question the need for what our doctor recommends. We do not ask if that CAT Scan is essential because we never see the full bill. We do not ask for generics if a new branded drug is covered. We do not push back if the dermatologist asks to take a piece of our skin to biopsy as long as it is covered. Once we have the limited pot of dollars under our control we will be much more involved in making the go/no go decision on treatment. We all know doctors err on the side of over treatment because they do not want to be sued. That defensive medicine will be reduced as we pay more of the bill.

The critics of consumer controlled free market health say people will avoid important tests and treatments to save money. This may in fact be a problem and under treatment could be an issue with consumer controlled limited dollar plans. What we hope for is that good health care information will tell consumers what are the best investments to keep them healthy. In other words which tests/services are critical and which are just nice to do. Like it or not all health care decisions are a cost/benefit calculation. We do not, as a society have unlimited resources. Trumpcare will place more burdens on us to decide how and how much to spend on health care.

One would hope that essential health care services become more easily available at lower prices. Competition should do that. We can expect more chain medicine as big providers will emerge who can use volume to offer lower priced services. That means many smaller, inefficient providers will be forced out. Clearly when price/value becomes the main concern of consumers the market will change significantly. Advertising will become critical to tell that price/value story as consumers will push back on providers to justify the recommended service or product.

In what might be the most puzzling FDA DTC study proposed to date, the agency wants to see if consumers can recognize deceptive claims in DTC ads. In this study FDA wants to create mock ads with deceptive claims to see if consumers recognize those false claims and evaluate how that affects their perceptions of and requests for the drug. FDA is concerned consumers might ask their doctor more often to prescribe a drug hyped with deceptive ad claims.

I have problems with this proposed study on many fronts. First, how are consumers supposed to know what is in the approved label to decide what is deceptive? In the study proposal apparently the plan is to plant false claims on a mock website and see if consumers can spot them. So FDA will have consumers play detective like those games where you see two photographs slightly altered to spot the changes? I just do not get the method here or how consumers should know what is an approved, accurate claim. Does FDA want consumers to be the vanguard of regulation and report claims they think are deceptive? Is FDA going to staff a hotline to receive consumer complaints?

Second, the consumer relies on FDA to prevent deception. Drug ads are already the most scrutinized ads in America. Most ads are pre-cleared well before they run. Consumers expect the claims in an ad to be vetted by FDA so what is the study goal in purposely putting in deceptive claims to see how misled is the consumer? I don’t understand an agency testing what would be the result of their own failure to effectively regulate DTC.

Third, what possible help could this study provide in future promotional guidances? False claims are already prohibited. Each branded ad must meet strict FDA criteria for fair balance. A study that proves consumers can be deceived and might be unable to know they are being deceived proves what? Is FDA trying to prove consumers who do not know what is in the approved label can be easily fooled by rogue drug companies? This study might be more appropriate for supplements or other non Rx drug health products that often make unproven efficacy claims in their ads. FDA seems to be asking a question they already know the answer to. If a drug makes deceptive efficacy claims, it is going to be more appealing to consumers. Hello, my new drug cures cancer. You interested?

Fourth, just by doing this study FDA is promoting a negative attitude against DTC. To study purposeful deception is to imply there is a broad history and likelihood that drug companies will engage in false ad making. In 20 years of television DTC ads, there are a only handful of ads that overstated efficacy. Those ads were withdrawn and in a few cases corrective ads were required. In other words why study deception when it almost never happens in DTC ads? Most warning letters are over subjective elements like distracting music or scenes, not over false claims. FDA already has procedures to punish deceptive ads. Is this deeper understanding using mock deceptive ads going to make FDA a better regulator?

Consumers deserve accurate and balanced DTC ads. Any study which helps improve those objectives are welcome. In this case, measuring how well consumers spot false ads does not, in my view, add to better ad development or regulatory guidance.