Requires the commissioner of health to establish and publish a list of generic drug products; repealer

Section two adds a new section 280-b, named "generic drug products," to the PHL. The provisions included in subdivision one are taken from paragraph (o) of subdivision one of section 205 of the PHL, which has been repealed. This new subdivision provides that the health commissioner shall establish a list of drug products, which must be certified or approved and evaluated as therapeutically and pharmaceutically equivalent by the Federal Food and Drug Administration. Subdivision two provides that the manufacturer of a generic drug product shall make available to the department of health the biopharmaceutic studies and summaries (including bioequivalence data and incidence of adverse events) and associated analytical methods (including dissolution data and test methods) provided to the FDA as part of the application for such generic drug product. The department shall make such information freely and publicly available on its website.

Section 3 and section 4 change the references to paragraph (o) of subdivision 1 of section 206 of the PHL in the Education Law.

Section 5 provides the effective date.

Justification

New York State Law (paragraph (o) of subdivision 1 of section 206 of the PHL) provides that the health commissioner shall establish and maintain a list of generic drug products, which must meet specified conditions. The bill repeals this paragraph and transfers its language to a new section (280-a) of the PHL, named "generic drug products." This way, the provisions related to generic drugs are easily accessible.

The bill also introduces a new provision (subdivision 2 of the new section 208-a) to make relevant information related to generic drug products freely and publicly available.

The Center for Drug Evaluation and Research defines a generic drug as a drug product that is comparable to a brand/reference listed drug product in dosage form, strength, route of administration, quality and performance characteristics, and intended use. Generic drugs are approved by the FDA and represent an affordable option for users. To receive approval by the FDA, generic drug manufacturers have to submit specified documents and reports, proving that their drug is bioequivalent to the respective brand name drug. The information that producers and manufacturers provide to the FDA is not publicly available. For most generic drugs, consumers can access such information only by going through a formal FOIL request. This process can be extremely difficult and time-consuming.

Moreover, the availability of such information is extremely valuable. The FDA has to process thousands of drug applications and mostly relies on studies submitted by the drug producers or manufacturers when making bioequivalence assessments.

Even when FDA procedures are precisely followed, differences between generic and brand name drugs can occur. For example, in 2008, the FDA declared a particular generic version of a brand name antidepressant drug as safe and effective. However, shortly thereafter it was discovered that the generic drug's side effects were different than those of the brand name drug. In 2012, the FDA reevaluated and announced that the generic drug is not the bioequivalent to the brand name drug.

The reversal was based on a FDA bioequivalence study which found that the generic drug achieved only 75% of the maximum drug concentration attained by the brand name product (potentially explaining the return of depression in patients switched to the generic product). The generic manufacturer's product released much of its drug earlier than the brand's product. The dissolution rate greatly affects how a drug is released in the human body. This ultimately impacts the drug effects. The new results obtained by the FDA closely matched the results of independent organizations that tested the two drugs for bioequivalence. If the information that this bill makes public was available immediately, the time for a correction to be made may have been less than four years.

The biopharmaceutic studies and summaries, dissolution data, and test methods provided to the FDA by generic drugs producers must be available. This way, such information can be reviewed and analyzed by experts who can conduct independent evaluations of the drugs.

The intent of the bill is to encourage transparency in order to protect consumers. Certainly, consumers should have the option to have their prescription filled with a generic product, particularly since generics often cost less than brand name drugs. However, consumers must be informed of the drawbacks, if any, of taking a generic drug instead of the brand name drug. Consumers have the right to know what the differences between brand and generic drugs are and decide, with their physicians and pharmacists, whether the generic product is appropriate for them.

Prior legislative history

2015: S.5099 - Referred to Health / A.145 - 3rd Reading Rules 2014: S.6739 - Referred to Health / A.8057 - Held in Ways & Means 2013: A.8057 - Referred to Health

Fiscal implications

None.

EFFECTIVE DATE :This act shall take effect on the ninetieth day after it shall have become a law.