The FDA’s Proposed Rule Supplemental Applications: Proposed Labeling Changes for Approved Drugs and Biological Products (here) occupied the podium time of many speakers at this year’s Generic Pharmaceutical Association’s (GPhA) Annual Meeting and was clearly on the minds of all attendees.   Ralph G. Neas, CEO and President of GPhA, was to testify before the House Energy and Commerce Subcommittee on Health on Monday March 3 to explain just what a detrimental impact on the generic industry the Proposed Rule, as currently written, will have on the generic drug industry, patients, and healthcare providers. Unfortunately, the weather postponed the hearing.

The Rule would allow any Generic applicant to make a unilateral change to its label to include new warnings and or safety information.  While on its face the proposal appears to speak to patient safety, in reality, the Rule strikes at the heart of the 30+ years of label sameness required by the Hatch-Waxman Act and FDA’s own current regulations.  The Hatch-Waxman Act struck a delicate balance between innovation for the brand industry and access to high quality generic products for consumers by providing special incentives, such as patent term restoration, patent listing provisions, and periods of various types of market exclusivity for NDA product.  GPhA‘s testimony alludes to some of the problems this Proposed Rule will create.

  • Increased costs – as outlined in a study performed for GPhA regarding the economic impact of the Proposed Rule (here) which estimated that the Rule will cost the American public some $4 billion dollars.
  • Confusion in the marketplace among physicians, nurses, pharmacists and patients by having multiple versions of warnings for the same product, thus creating the false impression that one product may not be equivalent to another.
  • The Rule would actually decrease patient access to certain drugs, as generic manufacturers may flee markets in fear of potential litigation, creating drug shortages and increased drug prices.
  • The law demands label sameness, yet the regulation appears to be in direct conflict with the plain working of the statute.
  • Generic manufactures only have a slice of the information on safety through their pharmacovigilance activities on their product.  On the other hand, the FDA has access to all adverse drug events reported by all of the marketers of a specific product, and thus, FDA is better positioned to evaluate this data and decide whether a label change is warranted.
  • Requiring generic makers to make unilateral label changes based on incomplete information will lead to a flood of unnecessary label changes, potentially exaggerating risk and inclusion of unsubstantiated warnings in an effort to avoid liability, thus creating confusion in the market place.
  • Brand and generic firms will be exposed to substantial tort liability costs.
  • These liability costs will also extend to pharmacists and other healthcare providers leading to an overall increase in pricing.

As Ralph Neas written testimony stated “The generic pharmaceutical industry will continue to work with the Congress, FDA, and other stakeholders to make sure that any changes to labeling rules and regulations protect patient safety, align with federal laws, and do not hinder patient access to more affordable generic medicines.”  The goal of all is to assure patient safety through an orderly and reasoned approach to label changes that will not disrupt the current sameness standard so as not to create wholesale confusion in the marketplace or to cause significant cost increases in generic drug prices that will result from implementing the Proposed Rule as currently written.  After all Hatch-Waxman has saved the government and consumers over $1.3 trillion over the last decade, let’s not take a step to reverse that trend.

An article was published today in Insidehealthpolicy.com today entitled “Democrats: Concerns About Drug Costs Under FDA Generic Labeling Rule ‘Unfounded’”.  Well, those Democrats should get off Capitol Hill and get out to the drug companies, the pharmacies, talk to healthcare providers instead of speaking or listening only to the Plaintiff’s bar.  The message we get from the rest of the world is that liability costs will increase dramatically, label change costs will soar, pharmacies too will incur both of these increases in cost as they have to deal with rising liability premiums and lawyers’ fees, as well as a constant change in the patient information sheets handed out with each prescription.  I have been a pharmacist for 42 years and have spent 30 years in FDA and the drug industry.  Come on Democrats (at least the ones that think this label change regulation as currently written is a good thing) – get real!  I did not get elected to any of the positions I held and thus I was not beholden to anyone I represented, I just did the best job I could for the American people and my clients.  There are numerous ways to assure the new information gets into labeling as soon as possible without creating the confusion the Proposed Rule will create.  And if the Democrats are really concerned about compensating patients that are injured by a drug – any drug because of new previously unidentified safety issues, they should be sure the labels are accurate, that the warnings are scientifically based and that the FDA agrees with the changes before they are made.  Also, they should investigate a program like the Vaccine Compensation Program if their interest is genuine as this will place the compensation in the hands of the patient and not attorneys that represent them.

For a complete copy of the GPhA testimony please visit the GPhA web site at http://www.gphaonline.org/issues/generic-drug-labeling