On January 12, 2016, the California state legislature will hold a hearing on AB 463: the Pharmaceutical Cost Transparency Act of 2016. The proposed bill would require drug manufacturers to disclose sensitive information about each drug with prices above a certain level. The required disclosure includes various production costs including: the costs of materials and manufacturing, the costs of research and development into the drug, the cost of clinical trials, the costs of any patents or licenses acquired in the development process, and the costs of marketing and advertising. Manufacturers would also be required to disclose a record of any pricing changes for the drug, the total profit attributable to the drug, the manufacturer’s aid to prescription assistance programs, and the costs of projects or drugs that fail during development. Similar bills have been proposed in other states.
The stated goal of the proposed Act is to ‘make pharmaceutical pricing as transparent as the pricing in other sectors of the healthcare industry.’ However, by focusing almost exclusively on cost disclosure, the bill seemingly ignores the fact that market price is determined by both supply and demand factors. Although costs of development and production are certainly an important factor, pricing is also based on factors such as therapeutic value, market size, available substitutes, patent life, and many other factors.
Moreover, the bill does not clarify how drug manufacturers are to account for and disclose one of the most significant costs to pharmaceutical manufacturers: the cost of failed drugs that never make it to market. Data suggests that only around 10 percent of drugs that begin clinical trials are eventually approved by the FDA. Drug companies depend on the profits from these “hits” in order to stay in business; companies must use the profits from successful drugs to subsidize the significant losses from the 90 percent of drugs that fail. AB 463 enables manufacturers to disclose the costs of failures, but is unclear if they are able to consider the total losses from the 90 percent of drugs that fail, or only failed drugs that were developed in conjunction with the drug in question. Moreover, even though profits from successful drugs are necessary to subsidize failures, AB 463 is silent on whether the losses from failures can be included in profit calculations.
It’s also worth pointing out that any evaluation of drug manufacturers’ profits should recognize the basic risk-return tradeoff. In order to willingly incur risk—and a 90 percent failure rate of drugs in development is a significant risk—investors and companies demand profits or returns greater than the return on less risky endeavors. That is, if investors or companies can make a 5% return on a safe, predictable investment that has little variation in returns, why would they ever engage in a risky endeavor (especially one with a 90% failure rate) if they don’t earn a substantially higher return? The market resolves these issues by compensating risky endeavors with a higher expected return. Thus, we should expect companies engaged in the risky business of drug development to receive higher profits than businesses engaged in more conservative businesses.
It will also prove difficult, if not impossible, for drug manufacturers to disclose information about even the “hits” because many of the costs that manufacturers incur are difficult to attribute to a specific drug. Much pre-clinical research is for the purpose of generating dozens or hundreds of possible drug candidates; how should these very expensive research costs be attributed? How should companies allocate the costs of meeting regulatory requirements; these are rarely incurred independently for each drug? And the overhead costs of operating a business with thousands of employees are also impossible to allocate to a specific drug. By ignoring these shared costs, AB 463 does little to illuminate the full costs to drug manufacturers.
Instead of providing useful information to make drug pricing more transparent, AB 463 will impose extensive legal and regulatory costs on businesses. The additional disclosure directly increases costs for manufacturers as they collect, prepare, and present the required data. Manufacturers will also incur significant costs as they consult with lawyers and regulators to ensure that they are meeting the disclosure requirements. These costs will ultimately be passed on to consumers in the form of higher drug prices.
Finally, disclosure of such competitively-sensitive information as that required under AB 463 risks harming competition if it gets into the wrong hands. If the confidentiality provisions prove unclear or inadequate, AB 463 may permit the broader disclosure of sensitive information to competitors. This will, in turn, facilitate collusion, raise prices, and harm the very consumers AB 463 is designed to protect.
In sum, the incomplete disclosure required under AB 463 will provide little transparency to the public. The resources could be better used to foster innovation and develop new treatments that lower total health care costs in the long run.