According to the report “The Future of Drug Safety: Promoting and Protecting the Health of the Public” issued by the Institute of Medicine (IOM), which is chartered by Congress to advise the government on scientific and health policy issues, “Lack of clear regulatory authority, chronic underfunding, organizational problems, and a scarcity of post-approval data about drugs’ risks and benefits have hampered the U.S. Food and Drug Administration’s ability to evaluate and address the safety of prescription drugs after they have reached the market.”

“FDA lacks the clear, unambiguous authority needed to enforce sponsor compliance with regulatory requirements and instead relies on the prospect of productive negotiations with industry,” according to the Report Brief.

The report had been requested by the FDA itself. Perhaps they got more then they asked for.

The IOM’s recommendations include:

  • Labeling requirements and advertising limits for new medications (ie, specifically a 2-year moratorium on DTC for new drugs — see below)
  • Clarified authority and additional enforcement tools for the agency
  • Clarification of FDA’s role in gathering and communicating additional information on marketed products’ risks and benefits
  • Mandatory registration of clinical trial results to facilitate public access to drug safety information
  • An increased role for FDA’s drug safety staff
  • A large boost in funding and staffing for the agency

See excerpts at the end of this post.

Spin Control from PhRMA
The response from PhRMA was lukewarm at best and aimed at spin control rather than at reassuring the public of the industry’s commitment to improving quality:

“We will review the 25 IOM drug safety recommendations to Congress in the context of knowing that what needs to be done is to make a good system better,” said PhRMA Vice President Caroline Loew. “Though there is always room for improvements, it would be a mistake to accept the notion that the FDA drug safety system is seriously flawed. After all, fewer than three percent of approved prescription drugs have been withdrawn from the American market for safety reasons over the last 20 years.”

Is a 3% Recall Rate Really “Good”?
The drug industry, through its trade association PhRMA, considers a 3% drug failure rate “good.” Obviously, the IOM doesn’t think a 3% failure rate represents a “good” system. In any other industry a 3% recall rate due to safety issues would be “bad.”

In the airline industry, for example, if 3% of airline flights ended in fatal crashes, there would be no airline industry. The actual rate of “fatal events” in the airline industry ranges from 0.00 to 1.92 per million flights. That’s less than than 0.0002%! Which is well within “Six Sigma” quality standards.

To achieve Six Sigma, a process must not produce more than 3.4 defects per million opportunities.

The pharmaceutical industry usually prides itself on striving for quality and many pharmaceutical companies — especially Johnson & Johnson — embrace Six Sigma methodology to achieve quality goals in manufacturing, marketing and sales (see, for example, “Growing Pharmaceutical Sales Utilizing Six Sigma and Lean“).

So why would the industry settle for a 3% failure rate for new drugs — about 10,000 times the defect rate allowed by Six Sigma? By Six Sigma standards, a 3% drug recall rate is not “good”. It’s not even “acceptable” or “poor.” It’s atrocious.

I am not suggesting that the pharmaceutical industry adopt Six Sigma as an achievable goal for reducing drug recalls. After all, that would amount to practically zero drugs recalled for safety reasons for the foreseeable future — obviously too much to expect in any research-based endeavor.

But, still, is a 3% recall rate all that “good?” To to adopt the “3% is good” defense in a public statement demonstrates PhRMA’s lack of public relations acumen.

Case for DTC Moratorium
If pharmaceutical companies want to be consumer-friendly and enjoy the right to market their products directly to consumers, then they must not settle for a 3% drug recall rate, IMHO. They may not have to go as far as Six Sigma, but how about at least Six Thousand Sigma (ie, a 0.34% drug recall rate)?

Excerpts from the Report Brief
Labeling Requirements: “Marking the label and all promotional material for newly approved drugs or indications with a special symbol [such as the black triangle used in the UK] will help increase awareness of the nature of newly approved therapies.”

“FDA should restrict direct-to-consumer advertising during the period of time the special symbol is in effect. The symbol should remain on the drug label and related materials for 2 years unless FDA chooses to shorten or extend the period on a case by case basis.”

Performance Goals for Safety: “The Prescription Drug User Fee Act mechanism that accounts for over half of the Center for Drug Evaluation and Research’s funding and the reporting requirements associated with the user-fee program are excessively oriented toward supporting speed of approval and insufficiently attentive to safety.”

Adequate Resources: “The effect on CDER’Â’s work of CDER’Â’s overdependence on PDUFA funding with restrictions on how FDA can use the money from user fees hurts FDA’s credibility and may affect the agency’s effectiveness. The committee favors appropriations from general revenues, rather than user fees, to support the full spectrum of new drug safety responsibilities proposed in this report.” See “Pay-(FDA)-Per-(Pre)View of DTC“.

Communication to the Public: “Patients also need timely information about emerging safety concerns or about a drug’s effectiveness in order to make better decisions in collaboration with their health care providers.” FDA started to do this, but abandoned the project. See “FDA Drug Watch Site Guidelines.”

For more on the topic of DTC advertisinig and risk communication, Fard Johnmar over at Envisioning 2.0 recommends the current edition of Pharma Marketing News which features a very interesting analysis of risk vs. benefit information in print DTC ads. Its worth a read. Click here to access the article.

Also see other related blog posts: