Congress Puts Pressure on FDA and Proposes Incentives to Ramp Up Generic Drug Reviews

By Kurt R. Karst –

The ongoing controversy over drug pricing has raised debate on many aspects of drug approval, and, in particular, on the approval of generic drugs.  Over the past several months, there have been numerous letters from Members of Congress to FDA – see, e.g., here, here, and here – seeking an accounting of ANDA reviews and the ANDA backlog, and criticizing FDA for being slow to act.  Even The New Yorker chimed in, saying that the “F.D.A. certification process for generic drugs is gruelling.” 

While the ANDA review process has historically been long – and in some cases quite exasperating – FDA’s Office of Generic Drugs (“OGD”) has made significant strides to improve the process as the Office implements the Generic Drug User Fee Amendments (“GDUFA”).  Last month, OGD Director Dr. Kathleen (“Cook”) Uhl provided a nice accounting of OGD’s progress under GDUFA I (see our previous post here).  Earlier this week, Lachman Consultants’ Bob Pollock noted in a blog post that OGD’s approval actions are increasing.

In February 2016, the House Committee on Oversight and Government Reform held a hearing at which some Representatives expressed disbelief that it could take 15 months or more for FDA to review and act on an ANDA. One exchange during the hearing, between Representative Blake Farenthold (R-TX) and OGD’s Keith Flanagan, was particularly entertaining (and yet also frustrating).  Representative Farenthold seemed to suggest that FDA’s OGD could just wave a magic wand – like a wand or swab used by the Transportation Security Administration at airports – to review and act on an ANDA.  Here’s a transcription of the exchange (which you can view here, minutes 1:40-3:50):

Farenthold:  The amount of time it takes the FDA to approve a generic drug manufacturer, that—if there’s only one manufacturer in the generic market—they’ve basically got the 15 months it takes—and I’m going to argue that number with you—they’ve got an exclusive ability to sell that drug for 15 months at a million dollars a pill if they choose to do that.

Flanagan:  Right.

Farenthold:  So, what takes so long to do this?  I’m not an expert in what’s involved in approving a place to manufacture drugs.  I assume if you can manufacture XYZ drug in a place, you’ve got a clean facility, there are no roaches on the assembly line.  If you want to add another product, why should it take 15 months to get that approved?  I assume you can test whatever drug they make and see if it is what they say.  What else is involved there?  And why—and if they do screw up making it, 1-800-BAD-DRUG is going to bankrupt the company.

Flanagan:  So, basically, to review a generic drug, there’s the scientific and technical review; bioequivalence; chemistry, manufacturing, controls; stuff like that. 

Farenthold:  How much of this is really necessary, and how much of it is regulations that are “what color is the toilet paper?”

Flanagan:  So, the reason we have 88% prescription penetration in the United States is because when you or your family go to the pharmacy to get a generic drug that you can be confident that it’s the same as the brand.  Our review—

Farenthold:  But, does it—why does it have to take 15 months?  How difficult is it to get their output, analyze it, and see what it is?  I can’t believe that takes 15 months.  The TSA can, in a matter of seconds, tell whether or not I’ve got an explosive in my bag by just swiping something on it.  I mean, isn’t there technology there that’ll make it faster and better?  Why aren’t we using it? Every day you delay getting a competitor on the market, is a day companies can screw the consumer.

Given the intense discussion around ANDA reviews and the need to get generic drugs to the market faster, it was inevitable that legislation would be introduced in an effort to tinker with the ANDA review process. 

Earlier this week, Senator Susan Collins (R-ME) introduced S. 2615, the “Increasing Competition in Pharmaceuticals Act” (“ICPA”).  In addition to requiring FDA to send to Congress quarterly reports on generic drugs (including the  number of ANDAs submitted to FDA, average and median approval times, and other figures), amending the tropical disease priority review voucher statute to require the submission of clinical studies to be eligible for a voucher, and requiring the Comptroller General to conduct a review of the implementation and effectiveness of Risk Evaluation and Mitigation Strategies (“REMS”) (including the burden of REMS on generic competition), the ICPA would amend the FDC Act to add Section 505(j)(11), requiring FDA to prioritize the review of certain ANDAs.  Here’s what the statute would be amended to state:

(11)(A) The Secretary shall prioritize the review, and act not later than 150 calendar days after the date of the submission of an application, on an application that has been submitted and accepted for review under this subsection, or on a supplement to such an application, that is for a drug that—

(i) has been introduced into interstate commerce by not more than one manufacturer or sponsor, as applicable, in the last 3 months and with respect to which tentative approval under paragraph (5) has been granted for not more than 2 applications; or

(ii) has been included on the list under section 506E [concerning drug shortages].

(B) The fees pursuant to section 744B(a)(3) shall be waived with respect to an application described in subparagraph (A), unless such application contains a certification under paragraph (2)(A)(vii)(IV).

(C) The Secretary may expedite an inspection or reinspection under section 704 of an establishment that proposes to manufacture a drug described in subparagraph (A).

How FDA will police the market to determine what drug “has been introduced into interstate commerce” is unclear.  And how will FDA handle the ever-changing content of the drug shortage list (FDC Act § 505E)?

The ICPA would also take the concept of Priority Review Vouchers (“PRVs”) into a new area.  As we previously reported (here and here), Congress has been exploring new ways to incentivize drug product development by, among other things, creating new statutory PRV provisions.  (As we reported earlier this week, not everyone at FDA has warmed up to the idea of PRVs.)  

Specifically, the ICPA would add Section 505G to the statute to create a new (and transferable) “Generic Priority Review Voucher” that would require FDA to review and act on an ANDA within 150 calendar days of submission and acceptance for review.  A Generic PRV would be awarded upon the approval of an ANDA described in FDC Act § 505(j)(11)(A) above, unless such ANDA contains a Paragraph IV certification.  A Generic PRV could be revoked if the product giving rise to the voucher is not marketed within 356 days from the date of ANDA approval.  The bill clarifies that nothing in proposed FDC Act § 505G  affects any period of patent or non-patent exclusivity applicable to a brand-name listed drug. 

Reminder: Register now for the May 3, 2016 Virginia Tech and HP&M Conference on Effective Documentation.  Information on the conference is available here.