On September 18, FDA approved the first medical device approved for ultrasound imaging for use in standard mammography screenings for women with dense breast tissue. Sunnyvale, California-based U-Systems manufactures the device called the somo-v® Platinum Automated Breast Ultrasound System (“ABUS”). The decision follows a unanimous recommendation to approve the device by an advisory panel.

 

 

Dense breasts have a high amount of connective and glandular tissue compared to breasts that have a higher percentage of fatty tissue. Physicians can determine whether a woman has dense breast tissue via a mammography exam. The National Cancer Institute currently estimates that about 40 percent of the women having mammography screening have dense breasts. These women appear to have a higher risk for breast cancer as well.

Mammography is a low-dose x-ray image of the breast. Until the ABUS, mammograms of breasts with dense tissue show both fibroglandular breast tissue and tumors as solid white areas on a mammogram, making results difficult to interpret. Often the dense breast tissue would obscure smaller breast tumors, which could delay breast cancer detection.
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generic-drugs.jpgA research letter published online in the Journal of the American Medical Association (“JAMA”) last Tuesday reports findings that pharmaceutical advertisements have a tendency to minimize potential adverse effects when the products they promote become available over-the-counter (“OTC”). The researchers attribute this shift in content to the differences in prescription drug advertising standards, governed by FDA, and those for OTC advertising, governed by the Federal Trade Commission (“FTC”). FDA requires that ads present a “fair balance” of the risks and benefits of a drug, a requirement that is absent from FTC’s “reasonable consumer” standard. Commentators note that the FDA regulations are better equipped to ensure against “active deception.”

The research endeavor, sponsored by CVS Caremark, considered four drugs that transitioned from prescription to OTC status within the last ten years: Claritin® (loratidine), Prilosec® (omeprazole), Xenical®/Alli® (orlistat), and Zyrtec® (cetirizine). It examined 133 total television and print advertising materials from twenty-four months prior to, through six months after, each transition, and found that the percentage of advertisements that referenced side effects plummeted from 70% while prescription only to 11% once available OTC. Conversely, the proportion describing drug benefits jumped from 83% to 97%. The study further reports that OTC advertisements frequently omit the generic names of drugs, “a powerful tool for the patient as a consumer in that it helps tie together scientific information on the drug from different places.” Roughly 50% of the OTC ads mentioned the generic name, while over 95% had when the drugs were available by prescription only.

Written by Rachael P. McClure

Thumbnail image for Thumbnail image for Thumbnail image for Thumbnail image for FDA.jpegFDA’s various user fee acts (“UFAs”) have not reached their implementation date in October 2012, yet FDA has already begun announcing staff changes to help with overseeing the new changes.

On the Commissioner level, Peter Lurie will be replacing David Dorsey as Acting Associate Commissioner for Policy and Planning. In a September 12 staff memorandum, FDA Commissioner Margaret A. Hamburg, M.D. announced the departure. Dorsey is leaving FDA to be a senior director in global regulatory policy and intelligence at Janssen Research & Development LLC in Rockville, Maryland. Hamburg wrote in the staff memorandum:

Throughout his long government tenure, David’s colleagues repeatedly have sought him out for his extraordinary depth of knowledge, his vast experience on the Hill and at the agency, his thoughtfulness, and his patience under pressure. . . . David’s departure will be a loss to the agency, and we will miss him.

(The Pink Sheet, September 13, 2012).

This changes follows a few earlier FDA staff changes at the Commissioner level and elsewhere last month. First, Associate Commissioner for Regulatory Affairs Dona Carrigan was announced as the new Director of FDA’s Europe Office and Senior Advisor for Global Operations, stationed in Brussels, Belgium. Carrigan’s new position is designed to help implement the Agency’s strategic and risk-based global industry oversight and enforcement. Next, Melinda Plaisier will be Acting Associate Commissioner for Regulatory Affairs effective October 1. Plaisier was previously the Regional Food and Drug Director in the Office of Regulatory Affairs’ central region, and before that she was Associate Commissioner for Legislation and Associate Commissioner for International Programs.
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Thumbnail image for dna.jpgOn September 12, FDA’s Center for Drug Evaluation and Research (“CDER”) Director Janet Woodcock, M.D. reported FDA’s biosimilars program will be “under-resourced” until the biosimilars industry develops at a Drug Information Association (“DIA”)/FDA Biosimilars Conference: Guidances, Science, and BsUFA. “This is going to be an under-resourced program for the next few years because that’s how it is … That’ll cause, I think, some struggle, especially with allocation of resources amongst all the important activities that we do at FDA,” Woodcock said. (The Pink Sheet, September 12, 2012.)

Once again, FDA reported that while FDA has the authority to approve biosimilars, FDA still has yet to receive a single biosimilars application, called 351(k) applications, based on their new statutory provision. FDA reported the same numbers that were discussed in two recent conferences discussing biosimilars that we reported on here and here: 11 investigational new drug applications (“INDs”) and 30 pre-IND meetings with the Agency concerning biosimilars. FDA recently did approve Teva’s biosimilar version of Amgen, Inc.’s Neupogen® (filgrastim), but Teva submitted this as a full biologics license application (“BLA”) rather than a biosimilar, because reportedly Teva believed the biosimilar pathway was either infeasible or not ready for commercial approvals yet.

Woodcock speculated that annual product fee payments for sponsors with INDs will likely be the initial source of extra funding that FDA receives, with 351(k) fees to follow only after sponsors start submitting these applications. Under the Biosimilars User Fee Act (“BsUFA”) that will become effective on October 1, 2012 along with other user fees, barring any possible derailment, which we reported here, the development fees are only 10% of the marketing application fees for each year, but the payments will be subtracted from the marketing application fee, once filed. For example, in Fiscal Year 2013, the product development fee for a 351(k) application is $195,880 with 351(k) application fees set at about $1.96 million per application.
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Thumbnail image for Thumbnail image for Thumbnail image for FDA.jpegOn January 2, 2013, barely three months after FDA’s new user fee programs go into effect, certain mandated spending reductions, called sequestration, also may go into effect that could prevent FDA from using the user fees it collects from industry. A Congressional Super Committee failed to find the required $1.2 trillion in cuts over ten years by a November 2011 deadline. The combined effect of lost taxpayer and user fees projected by Maryland-based Alliance for a Stronger FDA, would be an initial $294 million out of a $3.65 billion budget.

The catch comes from a component of FDA’s user fee programs known as the “trigger” that requires a certain baseline of taxpayer funds to go to FDA, so industry user fees supplement rather than fund FDA’s operations. FDA’s projected funding for fiscal year 2013, set at $2.5 billion, would be cut by an across-the-board, 8% cut in federal government, coined as a “fiscal cliff”, imposed to help curb the ever-increasing government debt. While FDA’s cut of about $200 million would not normally hit the trigger to prevent FDA’s use of user fees, Steven Grossman, Deputy Executive Director of the Alliance for a Stronger FDA, told Anna Edney from Bloomberg that the Obama Administration may still sequester FDA’s user fee funds to help with federal spending reduction goals. The exact trigger levels, moreover, are based on formulas that include consumer inflation and past spending, which so far FDA has declined to comment on.

According to Grossman, if this occurs, about $68 million in drug and device user fees and $40 million in tobacco-company payments would be diverted to a U.S. Treasury Department account that would “reduce government because it would reduce what they can do.” Faced with the sudden loss of these funds, drug industry experts have speculated that FDA would be forced to lay off personnel and take other measures to reduce costs.
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Charles Raubicheck, head of our firm’s FDA practice, will chair a panel and deliver an address at the “U.S. & Brazil Conference: Navigating New Frontiers in Pharmaceutical, Medical Device and Food Law and Regulation,” to be held on September 10-11, 2012 in Sao Paolo, Brazil.

The conference, sponsored by The Food and Drug Law Institute (“FDLI”), will bring together representatives of companies, venture capital firms, government agencies, law firms and other groups involved in the drug, device and food industries. They will engage in high-level discussions about respective commercial, trade, legal and other aspects of doing business in this country and Brazil, the world’s 6th largest economy.

Mr. Raubicheck’s panel will focus on the interplay between regulatory and intellectual property issues pertinent to pharmaceuticals. His presentation is entitled “NDAs, ANDAs, FDA’s Orange Book, and Patent Term Extensions.”

Thumbnail image for vaccine.jpgOn September 6, District of Columbia District Judge Amy Berman Jackson granted FDA’s motion to dismiss claims brought by K-V Pharmaceutical Company (“K-V”) either because the claims were unreviewable as discretionary FDA enforcement activities or failed to state a claim. Jackson’s Memorandum Opinion helps solidify FDA’s position that its discretion not to take an enforcement action is presumed to be immune from review unless Congress has otherwise provided “meaningful standards . .. for defining the limits of that discretion.” (citing Heckler v. Chaney),

Makena™ is essentially a story about K-V’s bid to take advantage of provisions under the Orphan Drug Act to obtain seven years of exclusivity to market the active ingredient in Makena™ (17-hydroxyprogesterone caproate) for women who have had a singleton pregnancy and a history of prior preterm delivery. Under the Orphan Drug Act, no other company can obtain approval to market the same active ingredient for this indication, which affects less than 200,000 patients per year in the United States, until this exclusivity would have expired. Prior to approval of Makena™, however, pharmacies had been compounding the same active ingredient for individual patients based on individual prescriptions–not a marketed product–at far less cost, around $10-20 per injection rather than the initial price of Makena™ at $1500 per injection, or up to $30,000 for the entire treatment. For more background, see, for example, an earlier blog here.

K-V had hoped that orphan drug approval would block competitors for seven years and its approval would make FDA take additional enforcement actions against pharmacies that had been routinely compounding the same active ingredient for the same indication. Indeed, many had feared, including a number of Congressmen, that FDA would take such actions, causing the cost of treatment to dramatically rise, under a general assumption that an approved drug product would be preferred, from a public health perspective, over a compounded product.
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FDLIBrazil.jpgFLH Partner Charles J. Raubicheck, head of our firm’s FDA/Regulatory practice, will moderate a panel and deliver an address at the upcoming Food and Drug Law Institute’s Conference “U.S. & Brazil: Navigating New Frontiers in Pharmaceutical, Medical Device and Food Law and Regulation.” The conference will be held on September 10-11, 2012 in São Paolo, Brazil.

Brazil has the world’s 6th largest economy, and is becoming a leader in research and development in the drug, medical device and food industries. The Conference is a forum for representatives of companies, venture capital firms, government agencies, law firms and other interested groups to focus on business opportunities and regulatory hurdles in both Brazil and the U.S. Speakers will include officials of FDA and the Brazilian National Health Surveillance Agency (“ANVISA”).

Thumbnail image for pediatrics.jpgThe Pediatric Committee (“PDCO”) of the European Medicines Agency (“EMA”) is tasked with identifying the needs for children in a variety of therapeutic areas and aims to encourage the research and development of pediatric medicinal products. The first Inventory, which is now open for discussion and public consultation, covers medicines for cardiovascular diseases. The EMA points out that it will be releasing similar lists for other therapeutic areas for public consultation during 2012 and 2013.

According to the EMA, the Inventory aims to enable:

  • Companies to identify opportunities for business development;
  • The PDCO to judge the need for medicines and studies when assessing draft pediatric investigation plans, waivers and deferrals; and
  • Healthcare professionals and patients to have an information source available to support their decisions as to which medicines.

The Inventory is based on a report on the survey of all pediatric uses of medicinal products in Europe completed by the PDCO in December 2010.
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Thumbnail image for Thumbnail image for Thumbnail image for Thumbnail image for Thumbnail image for drugmoney.jpegOn August 27, FDA published a Federal Register notice announcing the availability of industry guidance for generic drug user fees entitled “Generic Drug User Fee Amendments of 2012: Questions and Answers” and “Self-Identification of Generic Drugs Facilities, Sites, and Organizations.” Simultaneously with this notice, FDA also announced an upcoming public meeting on September 21, 2102 from 9 a.m. to 1 p.m. to discuss FDA’s implementation of the Generic Drug User Fee Amendments of 2012 (“GDUFA”). Finally, on the same day, another related Federal Register Notice issued: “Notice of Opportunity to Withdraw Abbreviated New Drug Applications to Avoid Backlog Fee Obligations.” Below is a snapshot of each of these items taken in turn.

GDUFA was signed into law on July 9, 2012 but the obligations arising therein begin on October 1, 2012. We have previously blogged on the genesis of GDUFA, when both the House and Senate passed GDUFA, for some background why and how we got here.

The GDUFA Q&A answers questions about the various types of fees (backlog fee, drug master file fee, generic drug submission fees (including a fee for active pharmaceutical ingredients (“APIs”) not referenced in a drug master file), and facility fees for APIs and finished dosage forms (“FDFs”)), self-identification of facilities, sites, and organizations, review of generic drug submissions, and inspections and compliance. For example, most immediately, backlog fees will be calculated based on the number of pending original abbreviated new drug applications (“ANDAs”) at the start of October 1, 2012. As was mentioned in a recent conference discussing this topic, a recommendation was made for all generic applicants to “clean house” and make sure that they did not pay fees for any pending ANDAs that they were no longer pursuing. FDA explains in this Notice that in accordance with GDUFA, FDA will divide $50 million by the number of pending ANDAs pending on this day to arrive at an individual one-time backlog fee due for each pending ANDA. Applicants wishing to remove pending ANDAs from this list, however, must do so by written notification received by FDA on or before September 28, 2012. Failure to pay the backlog fee is further explained, including a public disclosure of the failure to pay, and FDA will not receive a new ANDA or supplement submitted by that applicant “or affiliate” until the fee is paid. The GDUFA Q&A also explains when the various fees will be collected and the effect of not paying those fees timely. For new ANDAs or supplements, feed need to be paid when due, e.g., for new ANDAs, within 20 calendar days of the date that FDA provides notification that failure to pay will result in the ANDA or supplement not being receive and, therefore, reviewed.
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