Bill Would Give Some Reformulated Drugs Extra Protection from Generics

Regulatory NewsRegulatory News | 18 March 2015 |  By 

New legislation introduced in the US House of Representatives would give some pharmaceutical products an extra two years of marketing exclusivity if their sponsors are able to demonstrate that the redesigned or reformulated drugs improve adherence, decrease abuse or otherwise make the drug safer to take.


The bill, the Promoting Access for Treatments Ideal in Enhancing New Therapies (PATIENT) Act of 2015, was introduced in the House on 13 March 2015 by Rep. Gus Bilirakis (R-FL).

Find all FDA-related legislation in our FDA Legislation Tracker here.

The bill is focused less on the creation of new drugs and more on providing incentives to make existing drugs better.

Currently, if a company develops a new drug, it is given a certain amount of marketing exclusivity by the US Food and Drug Administration (FDA). For a chemical drug that has never before been approved, a company is given five years of protection; for an existing chemical drug approved for a new condition, a company is given three years of protection. Other amounts of marketing exclusivity also exist for biological drugs and drugs intended to treat rare diseases.

But a common problem of sorts has developed. Companies often work to improve upon their drugs after their initial release. For example, a company which gets a new pain drug approved will often work to develop more abuse-resistant versions of the drug to try to make it safer. Other companies might develop a once-per-day version of a drug which is more convenient for users than a three-times-per-day version.

However, these new versions aren't treated the same as the original drug by FDA. For example, if FDA approved a new, non-abuse-deterrent opioid, it would receive five years of marketing exclusivity. If, two years later, FDA approved an abuse-deterrent version of the same drug, it would receive only three years of marketing exclusivity. Unless the second drug had unique patent protections, both drugs would be subject to generic competition at the exact same time.

For some products, that's not necessarily a big deal. Legislators and public health officials have long been wary of attempts to "evergreen" products. The fear is that some companies would simply make incremental, minor improvements to their drugs in order to get new periods of exclusivity, and then pull their existing products off the market, forcing their patients to switch to the new version of the drug. One company's loss can be society's windfall.

For other products, however, a perceived lack of protections can discourage investments in product improvements like abuse-deterrent formulations.

Longer Periods of Exclusivity

As the PATIENT Act stipulates, additional incentives in the form of marketing exclusivity might result in more investment in better products, ultimately benefiting both patients and society.

Bilirakis' bill would give an extra two years of marketing exclusivity to drugs (including some generics) which are found by FDA to:

  • promote greater patient adherence to an approved treatment regime relative to the previously approved formulation or design of the drug
  • reduce the public-health risks associated with the drug relative to the previously approved formulation or design of the drug
  • reduce the manner or extent of side effects or adverse events associated with the previously approved formulation or design of the drug
  • provide systemic benefits to the health-care system relative to the previously approved formulation or design of the drug
  • provide other patient benefits that are comparable to the benefits described [above]

The bill could become controversial over its effects on product "evergreening." A reading of the text suggests FDA might not be able to differentiate between meaningful improvements to a drug and those which might be less important. As long as the drug product has been reformulated or redesigned and is supported by data "essential" to its approval, FDA would be required to grant the product a full five years of marketing exclusivity instead of the current standard of three. For some patients, that will mean an extra two years before cheaper generic drugs are allowed to come to market.

In a statement, Bilirakis said the bill is intended to provide FDA "with authority to review and recognize significant improvements upon previously approved therapies."

"This legislation has the potential to incentivize innovation of existing treatments by improving upon their effectiveness, efficiency, and safety,” Griffith said in the statement. “Patients, especially those with terminal illnesses, deserve faster and better cures, and this bill is a solid step towards achieving this goal.”

The bill has the support of several patient advocacy groups, Bilirakis noted.

The language contained within the bill should be familiar to close readers of the most recent draft of the 21st Century Cures Act. Title I, Subtitle M contains identical language.


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