FDA Makes it Easier to Bring Generic Copies of Dangerous Drugs to Market

Regulatory NewsRegulatory News | 04 December 2014 |  By 

A new draft policy issued by the US Food and Drug Administration (FDA) would makes changes to a complicated safety policy in the hopes of making it easier for generic drug manufacturers to make cheaper copies of dangerous drugs.


To understand FDA's change, you need to understand quite a bit about REMS—Risk Evaluation and Mitigation Strategies.

REMS were first introduced under the 2007 Food and Drug Administration Amendments Act (FDAAA), and were meant to ensure the safe use of potentially risky products that might otherwise not be approved for use.

REMS typically include the following elements: A communication plan, Medication Guides (MedGuides), an implementation plan and elements to ensure safe use (ETASU) of the drug.

ETASU's are REMS' most stringent requirements and include prescriber requirements, enrollment forms, training materials, process controls, consent forms, safety controls and monitoring programs. Some REMS will only include one or two of these elements, while others, such as the REMS for isotretinoin or Thalomid, may include nearly all of them.

The overarching goal of an ETASU is this: Keep drugs out of the hands of patients who won't benefit, and ensure that those who do receive the product use it correctly. Human rights campaigners have even tried to use it to keep certain drugs from being used at a US military facility located at Guantanamo Bay, Cuba (to no success).

But as branded pharmaceutical companies have found out, REMS with ETASUs have another handy use: keeping patent-protected drugs out of the hands of generic pharmaceutical manufacturers who want to make copies.

Using REMS to Restrict Competition

As Focus noted in May 2012, companies have been using REMS to stifle their market competition for quite some time. ETASUs, in particular, have been used to tightly control access to drugs, ensuring that generic drug companies can't get their hands on the products to reverse-engineer their production.

While government competition regulators at the Federal Trade Commission (FTC) have expressed concern over the practice, they have thus far decided not to intervene. And in the meantime, there have been other REMS-related market access issues as well. As we wrote in October 2013, another statutory requirement under FDAAA that all companies institute a single, shared REMS plan for their drugs has also been used to prevent and delay market access for some drugs, leading to calls for FDA to step in (which it has not).

The Generic Pharmaceutical Association (GPhA) has recently highlighted the issue, and commissioned a study which found that delayed market entry due to REMS and REMS-like restrictions cost US consumers north of $5 billion per year in higher drug costs due to reduced generic competition.

Since then, legislation has been introduced in the House of Representatives which would require brand-name pharmaceutical companies to make their products available to generic drug manufacturers "as a condition of approval or licensure." Under the bill, companies would also be allowed to make a written request to FDA for access to a product, which could compel the NDA holder to grant access. Generic companies would be able to access "reasonable quantities" of a product at a "reasonable, market-based price."

Read the text of the FAST Generics Act of 2014 here.

New Draft Guidance

While the FAST Generics Act hasn't yet been passed by either the House or Senate, FDA is now moving forward with its own plan to allow generic drug companies to get around REMS-based restrictions.

Under a new draft guidance document, How to Obtain a Letter from FDA Stating that Bioequivalence Study Protocols Contain Safety Protections Comparable to Applicable REMS for RLD, generic drug companies could ask FDA to determine that their study protocol protections are "comparable" to those required under the REMS for the brand-name drug.

FDA would also be able to attest that it would "not consider it a violation of the REMS for the RLD sponsor to provide a sufficient quantity of the Reference-Listed Drug (RLD) [i.e. the brand-name drug] to the interested generic firm or its agent to allow the firm to perform the testing necessary to support its Abbreviated New Drug Application (ANDA)." [i.e. the generic drug]

FDA's stated purpose for the guidance is to work around "instances in which an RLD sponsor has refused to sell drug product to a prospective ANDA applicant seeking to conduct the testing needed to obtain approval," it said. In at least some of those cases, the owner of the RLD has maintained it could not supply any quantity of the drug for fear of violating its REMS agreement with FDA.

FDA's new policy dismantles that excuse, but it does not compel action on the part of any party. FDA notes that its guidance "is not a legal requirement." As with nearly all guidance documents, it is merely a statement on how it plans to enforce its existing authorities.

Notably, the guidance does not compel an RLD holder to sell its drug to a prospective ANDA applicant; it merely authorizes them to do so if they are willing. While that will make it easier for companies to help their generic competition, it's unclear how many—or if any—companies will opt to be so helpful.


How to Obtain a Letter from FDA Stating that Bioequivalence Study Protocols Contain Safety Protections Comparable to Applicable REMS for RLD (FR)


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