House Adds Provision to Allow DoD to Approve Medical Products Outside of FDA

On Monday, the Rules Committee of the House of Representatives will adopt a provision that would expand the ability of the US Department of Defense to urgently approve medical products, according to the US Food and Drug Administration Commissioner. United (FDA) Scott Gottlieb for the provision to be rejected

According to the committee conference report on the National Defense Authorization Act for fiscal year 2018, the House will add the Senate amendment to authorize the Secretary of Defense to approve the emergency use of medical products outside of the US. UU., Expanding the capacity of the Department of Defense to approve these products.

"Participants agree that the traditional routes for the approval and authorization of the Food and Drug Administration of critical medical products for the care of combat victims are too slow to allow a rapid insertion and use of these products on the battlefield "said the report.

Speakers in the House noted "even higher survival rates due to severe combat injuries and injuries suffered by service members" as a reason to add the provision, although they said they expect the FDA to be consulted when evaluating medical products for the care of combat victims and use this new authority strictly for the approval of medical products for injuries and injuries on the battlefield. "

The FDA and the Department of Defense are already working together on the emergency use authorizations (EUA), including the DoD presentations, in accordance with the FDA's guidance on the use of said US as of January. For example, in 2014, the FDA issued an EUA to authorize the use of the EZ1 Real-Time DZ-PCR Assay of the Department of Defense for the detection of Ebola Zaire virus during the outbreak in West Africa.

The decision to add the provision to the House bill followed Gottlieb's comments earlier this week, which is rare for an agency that often says it will not comment on pending legislation, which must maintain such approvals within the scope of the FDA. The former commissioners of the FDA have also had problems with the provision.

And the move to carry it out in the House committee on Monday may not indicate that the change is final. Senator Patty Murray (D-WA) told Axios that an agreement had been reached with Senator Lamar Alexander (R-TN) to maintain US reviews under the FDA, but the DoD could pressure the FDA to expedite certain product reviews.

Pay-for-Delay Deals: FTC Notes Continued Decline Since SCOTUS Ruling

The total number of transactions in which brand-name drug companies pay to delay the entry of generic competitors continues to decline, and only 5 of 170 final 2015 settlements included generic compensation and entry restriction generic, the Federal Trade Commission (FTC) said in a report released on Wednesday.

Fiscal 2015 is the second full year of filings since the Supreme Court ruled FTC v. Canada. Actavis, Inc. in June 2013, when it concluded that a drug company's transfer to a generic competitor to settle a patent dispute could violate antitrust laws. The decline in fiscal 2015 follows a similar decline revealed in a report from the FTC last year.

"In accordance with the 2014 fiscal year, the number of settlements that can lead to late payment continues to decline significantly as a result of the Actavis decision, even though the total number of settlements filed with the FTC has increased," the report says.

During the 2015 financial year, the total number of definitive settlements was 170, compared to 140 in 2012, 145 in 2013 and 160 in 2014. However, the number of potential deferred payment agreements fell to 14 in 2015, from a high of 40 late payment settlements for fiscal year 2012.

Of these 14, 10 included compensation in the form of a cash payment only for litigation costs (one of which included a cash payment of more than $ 7 million), while the other four included a promise of non-commercialization. an authorized generic in competition with the generic manufacturer for a period.

Ten additional definitive regulations are classified by the FTC as containing "possible compensation" because it is not clear whether certain provisions in the agreements are equivalent to what should be considered compensation for the generic patent applicant.

"For example, an agreement containing a declining royalty structure, in which the generic's obligation to pay royalties is reduced or eliminated if a brand launches an authorized generic product, can have the same effect as an explicit commitment without MGAs. ", says the report. .

In addition, 126 of the 170 final regulations limited the ability of the generic manufacturer to market its product, but did not include explicit or possible compensation ...