By Alan M. Kirschenbaum & Kurt R. Karst –

Last Thursday we reported on the release by the House of H.R. 3962, the health care reform bill that will soon be considered on the House floor.  As we have done with other health care reform proposals, we have prepared a summary of the provisions of H.R. 3962 that are of direct interest to pharmaceutical and medical device manufacturers.  Our summary can be found here.  The full text of the bill can be found here. 

By Ricardo Carvajal –

FDA has again posted a warning letter to Procter and Gamble stating that the company’s VICKS DayQuil Plus Vitamin C and VICKS NyQuil Plus Vitamin C are unapproved new drugs and are  misbranded.  The letter states that, when “drug and dietary ingredients are combined into a single dosage form, the combination becomes a drug under section 201(g)” of the FDCA.  As noted in the letter to P&G, FDA previously staked out that position in warning letters in October 2008 to Bayer for its products combining aspirin with either phytosterols or calcium, and in 2001 to Omni Nutraceuticals for its products combining acetaminophen with either glucosamine sulfate or glucosamine sulfate and chondroitin sulfate, and to B.F. Ascher its product combining  acetaminophen and melatonin. 

FDA first posted a warning letter to P&G over VICKS on October 14, but then removed the posting, citing an administrative error.  The fact that this latest posting is accompanied by a press release emphasizes that this time it’s for real.

By Ricardo Carvajal –

We’re used to seeing the Center for Science in the Public Interest ("CSPI") take a stick to food marketers.  It seems that CSPI now has plenty of friends.  First, Connecticut’s Attorney General trumpeted his success in gaining agreement from food companies to stop using the Smart Choices logo, at least until FDA decides what to do about point-of-purchase labeling (for more on that controversy, see our prior post).  Then according to Sustainable Food News, Hain Celestial  called for industry to stop using misleading front-of-pack labeling and to stop playing fast and loose with its use of “natural.”  Hain Celestial is proposing the adoption of standards for “natural” similar to those used for “organic” (for our primer on “natural,” “organic,” and other “green” claims, see here).  Now The Economist is piling on with an opinion that calls for greater scrutiny of health-related promotional claims. 

For food marketers, it’s bad enough that regulators, the media, and even some in industry are on the case.  But as the Food Liability Blog points out, it may yet be the plaintiffs’ bar that does the most damage.

JP Ellison –

In March of 2008, we reported on a Wisconsin federal district court opinion that dismissed a plaintiff’s Lanham Act claim against three manufacturers of generic prescription drug products.  On October 29, 2008, the Seventh Circuit issued a decision in an appeal of that same case.  As we noted in our earlier post, Hyman, Phelps & McNamara, P.C. represented one of the defendants in the case. 

Between March of 2008 and October 2009, the district court had modified its dismissal from with prejudice to without prejudice and the plaintiff and two of the defendants had appealed and cross-appealed, respectively.

The central issue before the Seventh Circuit was whether a Lanham Act claim could proceed when the claim was based upon FDA-required labeling. On appeal, the panel (in an opinion written by Judge Posner) agreed with the district court’s reasoning that such a claim could not proceed unless and until FDA had made a finding with respect to that labeling, which it had not yet done.  In concluding that FDA had not yet made a finding, the Seventh Circuit reached the same conclusion as the district court, namely that letters from an FDA employee to the defendants did not constitute final agency action.

The Seventh Circuit also affirmed the district court’s denial of the plaintiff’s motion for partial summary judgment based upon a claim of “literal falsity.”  In doing so, Judge Posner observed:  “William Blake declared that ‘to Generalize is to be an Idiot.  To Particularize is the Alone Distinction of Merit.’  That is a bit extreme, but uncritical generalization is the path to error.”  We’re not sure the quote is central to the court’s holding, but it seemed a shame to omit a William Blake quote from a report on an appellate court opinion.

By William T. Koustas –

On October 29, 2009, Judge Walton of the United States District Court for the District of Columbia ruled for the American Bar Association (“ABA”) and prevented the controversial Red Flags Rule (“the Rule”) from being enforced on November 1, 2009 with respect to lawyers.  (See our previous post here.)

The ABA filed suit against the Federal Trade Commission (“FTC”) on August 27, 2009.  On September 23rd, the ABA filed a motion for summary judgment and declaratory and injunctive relief insofar as the Rule could be deemed to apply to attorneys.  According to media reports, Judge Walton had trouble accepting the FTC’s characterization of lawyers being considered “creditors.”  He noted that the FTC’s definition of a creditor could even include a plumber who bills a customer for work and said he has “…a real problem with concluding that Congress intended to regulate lawyers when these statutes were enacted.” 

The ABA released a short statement following its victory which states, “[b]y voiding the FTC’s interpretation of a statute that was clearly not intended to apply to the legal profession, the court has ensured that lawyers stay focused on the mission of their work…”  

Though this decision apparently only applies to lawyers, it is possible it could have broader implications. 

UPDATE:

• FTC extends enforcement deadline for Red Flags Rule until June 2010.

By Kurt R. Karst –      

A recent report issued by the London School of Economics and Political Science (“LSEPS”), and commissioned by the Swedish government, urges governments to create new incentives to promote the research and development of antibiotics in light of the growing concern over resistance to existing antibiotics, such as the emergence of drug-resistant “superbugs” like Methicillin-resistant Staphylococcus aureus, which reportedly kills approximately 18,650 Americans each year.  Sweden, which currently holds the rotating European Union (“EU”) Presidency, will reportedly lobby EU and U.S. officials to push for legislation creating new incentives for antibiotic drug development.

According to the report, titled “Policies and incentives for promoting innovation in antibiotic research”:

The potential for an impending health crisis due to the lack of new antibiotics, along with the inherent externalities in the market and the likely cost-savings from improving treatment, provide ethical and economic justification for some intervention in the market by a public body.  However, the design of the incentive – in terms of the timing and size of the prize, the organisational driver, and the target beneficiary – will determine its chances of success.

The LSEPS report goes on to divide “traditional” R&D incentives into two main types – “push” and “pull” methods.  “Push incentives focus on removing barriers to developer entry largely by affecting the marginal cost of funds to the developer for investments in R&D and tend to impact the earlier stages of the development process,” and include tax credits and grants, according to the report.  Meanwhile, “pull mechanisms involve the promise of financial reward only after a technology has been developed,” and include monetary prizes, and intellectual property extensions.  (The idea of creating a “Medical Innovation Prize Fund” and abolishing non-patent market exclusivity has been proposed in the U.S. by one member of Congress; however, the idea has not gained traction.  The recent creation of priority review vouchers in the U.S. is one new “pull” mechanism, but because the priority review voucher market is untested, it is unclear how successful this incentive mechanism will be.)  The report goes on to note that:

The basic elements of push and pull mechanisms can also be combined to create hybrid mechanisms. . . .  Hybrid mechanisms may provide crucial impetus to overcome developer reticence at the different (and perhaps key) stages of product development: early stage push funding provides greater financial space to explore early discovery ideas without needing to understand their full potential, whilst the larger pull element entices them to undertake the latter phases of development, including expensive Phase III trials.  The evolution between the respective incentive forces within a hybrid incentive (push to pull) is important in that developers have been understood to respond more to profit incentives at the later stages of the research process than at the earlier stages. In combining push and pull incentives, hybrid mechanisms also spread risk between the funder and the developer.

Among other incentives identified in the 199-page report, the report discusses regulation-based incentives, such as reducing clinical trial requirements.  This could include delaying Phase 3 clinical trials until post-approval for drugs for very serious infections, and accepting more evidence based on modelling predictions.  To that end, earlier this year, legislation co-sponsored by Senators Sam Brownback (R-KS) and Sherrod Brown (D-OH) was enacted that requires FDA to establish two new review groups to recommend solutions for the prevention, diagnosis, and treatment of rare diseases and neglected diseases of the developing world.  These two groups must recommend to FDA “appropriate preclinical, trial design, and regulatory paradigms and optimal solutions for” rare and neglected diseases.

The report also notes that “pharmaceutical companies may hesitate to initiate new clinical trials for antibiotics because guidelines for clinical trials in this therapeutic area remain unclear.”  Over the past couple of years, FDA has held several meetings to discuss clinical trial design issues for antibiotic drug development, and recently scheduled a meeting of the Anti-Infective Drugs Advisory Committee to discuss clinical trial endpoint and design issues in the development of antibacterial products for the treatment of community-acquired bacterial pneumonia.  In addition, the FDA Amendments Act of 2007 – at Title XI, Subtitle B (Antibiotic Access and Innovation) – requires FDA to convene a public meeting on serious and life-threatening diseases due to antimicrobial resistance and to make available on FDA’s website any clinically susceptible concentrations (i.e., values that characterize bacteria).

Also of interest, the LSEPS report addresses the issue of so-called “wildcard” patent term extensions (“PTEs”).  “Under wildcard patent extensions, also known as transferable IP protection, a company that successfully develops a new antibiotic is granted a patent extension for another drug that is approaching patent expiration in its portfolio.  Suggested lengths of the patent extension range from 6 months to 2 years in the US and to up to 5 years in the EU or proportional to therapeutic benefit,” according to the report.  After noting the various advantages and disadvantages of wildcard PTEs (“The main advantage of the scheme is that it would present a significant reward for large companies with lucrative products to protect or for small companies who could sell the extension to them. . . . [T]he main disadvantage of the scheme is the significant social costs of a wildcard patent extension. The estimated cost of allowing wildcard patents for just 10 drugs exceeds US $40 billion.”), the report concludes that “[w]ildcard patent extensions should not be considered for promoting R&D in antibiotics.” 

The idea of creating a wildcard PTE has been proposed and rejected in the U.S.  This pull mechanism was most recently proposed in the Biodefense and Pandemic Vaccine and Drug Development Act of 2005 (Bioshield II), which is intended to stimulate the development and approval of countermeasures to biological weapons.  Bioshield II was signed into law, but without the proposed wildcard PTE provision.

By Jeffrey N. Wasserstein –
 
On October 28, 2009, Michael Loucks, the Acting U.S. Attorney for the District of Massachusetts, announced that his office has recovered over $6.8 billion in healthcare fraud cases over the last 15 years, which is almost 30% of the total healthcare fraud recoveries in that time period in the U.S.  This includes the recent $2.3 billion settlement with Pfizer.  If you read the list of companies in the press release that have paid more than $50 million, twelve of the 14 companies are pharmaceutical or medical device companies. 

Where will the prosecutors from Boston be trick or treating next?  Scary times for pharma and the medical device industries. 

By Alan M. Kirschenbaum & Kurt R. Karst –

Earlier today, House Speaker Nancy Pelosi (D-CA) unveiled the Affordable Health Care for America Act (H.R. 3962).  The bill, which is the latest version of the House’s healthcare reform proposal and the one that will go to the House floor, is almost 2,000 pages in length.  A section-by-section analysis of the bill is available here.  Various other documents related to the bill are posted on the House Energy and Commerce Committee website.  (A second, and much shorter bill – H.R. 3961, the Medicare Physician Payment Reform Act of 2009 – was also introduced.)

Some of the provisions that will be of most interest to FDA Law blog readers are the following:
 
Federal Food, Drug, and Cosmetic Act and Public Health Service Act amendments

• Pathway for licensure of biosimilars established (§§ 2575-2577)
• National directory for Class III and certain Class II devices established (§ 2571)
• Patent infringement settlements between brand and generic manufacturers that delay generic entry (“reverse payments”) prohibited (§ 2573)
• Nutrition labeling required for standard menu items at chain restaurants (§ 2572)

Public Option

• HHS may negotiate payment rates for items and services, including prescription drugs (§ 323)
• Federal health care program fraud and abuse laws apply to public option (§ 326).

Medicare Part D

• Drug manufacturers provide discounts of 50% on brand drugs dispensed to enrollees in the coverage gap (§ 1182)
• Coverage gap phased out by 2019 (§ 1181)
• Repeal of non-interference provision:  HHS may negotiate prices with drug manufacturers (§ 1186)
• Drug manufacturer rebates required for drugs dispensed to Medicare/Medicaid dual eligibles (§ 1181)

Physician Payment Sunshine

• Requires reports on payments of value by drug and device companies to physicians and other health care providers (§ 1451)

Medicaid

• Federal upper limits on Medicaid payment for multiple source drugs changed to 130% of weighted average of AMPs (§ 1741)
• AMP definition amended to exclude sales to most non-retail pharmacy entities (§ 1741)
• Minimum Medicaid Rebate for innovator drugs increased to 22.1% of AMP and rebates increased for new formulations  (§ 1742)
• Rebates required for drugs dispensed to Medicaid managed care enrollees (§ 1743)

340B Program

• Program expanded to certain cancer hospitals, critical access hospitals, and other new covered entities (§ 2501)
• HRSA oversight enhanced (§ 2502)

Other provisions

• New 2.5% excise tax on non-retail sales of medical devices (§ 552)
• HHS to conduct study on use of physician prescriber information in sales and marketing by drug manufacturers, and recommend ways to protect providers from biased marketing (§ 239)

We’ll be posting a more detailed summary of these and other H.R. 3962 provisions of interest to our readers in the near future.

The House Democratic Leadership intends to begin floor debate on the bill beginning on Thursday, November 5, and members have been asked to be  prepared to vote over the following weekend in order to complete the bill. 

By Dara Katcher Levy –

On October 21, 2009, First Fishery Development Services filed suit against FDA seeking declaratory judgment and injunctive relief with regard to its product’s placement on Import Alert 99-08 – Detention Without Physical Examination of Processed Foods for Pesticides.  According to the Complaint, the Company contends that its bulk Olive Leaf Powder Extract is not adulterated, in violation of section 402(a)(2)(b) of the Federal Food, Drug, and Cosmetic Act (“FDC Act”), because the presence of a pesticide in the product is a result of the presence of the pesticide in an antimicrobial solution used on food contact equipment.  The Company contends that this use of the pesticide conforms to an exemption from a pesticide tolerance granted by EPA and is permissible under FDA's threshold of regulation program for substances used in food contact articles that migrate into food.     

The Company alleges that FDA first placed the Olive Leaf Powder Extract on Import Alert on July 2, 2009.  According to the Complaint, the Company states that the original shipment upon which FDA raised the adulteration charge and that is the basis for placing the Company’s product on Import Alert, has not been the subject of final agency action.  The Company maintains that the product is still on “detention status.” 

This is where things get interesting.  Typically, FDA will “Refuse” a shipment before placing a product or entity on an Import Alert. (See our recent article in the Food and Drug Law Institute’s Update publication explaining how FDA generally deals with import matters.)  Although issuing a Refusal before placing on Import Alert is typical FDA practice,  FDA’s procedures for placing products or entities on Import Alert (or Detention Without Physical Examination – DWPE) do not require the issuance of a Refusal and may be based on a finding of one violative sample.  See FDA Regulatory Procedures Manual (“RPM”) Chapter 9.   This departure in practice is yet another sign of FDA’s increase in enforcement activity against imports.

First Fishery alleges, among other things, that for FDA to recommend DWPE based on one violative sample, FDA must have evidence that at least one sample has been found violative and the violation represents a potentially significant health hazard.  This is, in fact, FDA’s stated procedure (RPM Ch 9, 9-21).  However, under the authority of the FDC Act, FDA may take action against a shipment without the existance of an actual violation; section 801(a) provides that FDA may refuse admission to articles that “appear” to be violative.  The burden is on the importer to overcome the appearance of a violation.  

Given the discretion afforded to FDA in the FDC Act over imports, we have no doubt that FDA will present myriad arguments that First Fishery’s case is without merit.  We will be watching this case, as well as the recent case filed against FDA over a tobacco-related product Import Alert. 

By Susan J. Matthees –

On October 27th, on the heels of the release of the Government Accountability Office’s report in which the Office is critical of FDA’s oversight of clinical investigators (see our previous post), Rep. Joe Barton (R-TX) introduced H.R.3932, the Strengthening of FDA Integrity Act of 2009.  The bill, if enacted, would amend the FDC Act to give FDA greater authority to debar individuals, including clinical investigators, from working with drug or device approvals.  The bill has seven Republican co-sponsors.  A summary of the bill provided by Rep. Barton is available here.

By JP Ellison –

Last year we posed the question “Are the Stars Lining Up for FDA Civil Penalties?”   The intervening year has not answered that question, but a recent decision from the Tenth Circuit affirming civil penalties against TMJ Implants, Inc. (“TMJI”) and its founder and president Robert Christensen serves as a reminder of this FDA enforcement tool.  In last year’s blog post we referred to an earlier Food and Drug Law Institute article discussing civil money penalties (CMPs) generally, and the TMJI case specifically.

At that time, the penalties had not yet been assessed in the case.  Subsequently, the administrative law judge (“ALJ”) assessed CMPs totaling $170,000, which represented a $10,000 penalty for failure to submit 17 medical device reports (“MDRs”).  The maximum penalty allowed by regulation for each violation was $165,000.  Yesterday, the Tenth Circuit affirmed a decision of the HHS Departmental Appeals Board (“DAB”), which had, in turn, affirmed the ALJ’s decision.

The central issue in the case was whether MDRs were required despite TMJI’s claim that it did not believe the events in question (either explants of the device or antibiotic treatments) were caused by the device, and thus did not need to be reported.  FDA employees had been telling TMJI since a February 2004 Warning Letter that the events needed to be reported.  TMJI steadfastly refused.  After more than a year of correspondence, FDA filed an administrative CMP action, which resulted in the penalties that the Tenth Circuit affirmed.

For those followers of the Park doctrine, the Tenth Circuit opinion contains a brief, but potentially important discussion of the relevance of Park to CMPs.  In its decision, the Tenth Circuit affirms CMPs against TMJI’s founder and president, Dr. Christensen and cites Park.  Significantly, the government believes that Park stands for the proposition that strict criminal misdemeanor liability can be imposed on a responsible corporate officer regardless of whether that individual knew of the violation.  In contrast, the CMPs in the TMJI case were imposed for “knowing” violations.  While the facts may have well shown that Dr. Christensen knew of the violations, that was not the basis for the Tenth Circuit’s decision.  Rather, it extends Park’s rationale to CMPs. 

By Susan J. Matthees –

Last month the Government Accountability Office ("GAO") published a new report ("GAO report") on the oversight of clinical investigators.  The report is critical of FDA’s oversight of clinical investigators, citing numerous instances where FDA did not take timely action to respond to situations where debarment or disqualification of a clinical investigator was at issue. 

Under Federal Food, Drug, and Cosmetic Act ("FDC Act") section 306, there are certain situations in which FDA must or may debar an individual (including a clinical investigator) from providing any service to a person who has an approved or pending drug application.  In a mandatory debarment, FDA must debar an individual if he or she has been convicted of a felony under federal law for conduct relating to the regulation of a drug.  A mandatory debarment is permanent.  In a permissive debarment, FDA may debar an individual if he or she has been convicted of a misdemeanor under federal law or a felony under state law if the conduct relates to the development or approval process of a drug, or if the individual has been convicted of certain felonies not related to drug development.  Permissive debarment is for a period of time up to five years. 

Pursuant to FDA regulations, FDA may also disqualify investigators (i.e., determine that an investigator is not entitled to receive investigational drugs or devices) who repeatedly or deliberately fail to comply with FDA regulations or report false information to FDA or a trial sponsor.  21 C.F.R. §§ 312.70, 812.119. 

The GAO reviewed 18 debarment proceedings and 52 disqualification proceedings and found that debarment proceedings ranged in length from 26 days to more than a decade.  More than half of the debarment proceedings took over 4 years, and the median length for a proceeding was 4.4 years.  The median length for a disqualification proceeding was 2.5 years, with over a third of the proceedings taking more than 2 years. 

The GAO report cites internal control weakness and limited resources as factors in delay.  The report also comments that FDA’s overall authority “is limited . . .  because FDA’s regulations do not extend a clinical investigator’s disqualification for investigational drugs and biologics to investigational devices and vice versa.”  The report includes the following recommendations (GAO Report page 43):

• Pursue debarment authority for medical devices that is consistent with the current debarment authority for drugs and biologics and prohibit any debarred individual from involvement with drugs, biologics, and medical devices.

• Amend FDA regulations to ensure that those who have engaged in misconduct found sufficiently serious to warrant disqualification for one investigational medical product are not able to continue to serve as clinical investigators for any.

• Monitor compliance with recently established time frames for debarment and disqualification proceedings and take appropriate action when those are not met.

According to the report, FDA is working to improve its debarment and disqualification procedures and will “endeavor to incorporate” the GAO’s recommendations.   FDA also stated that the Agency would be drafting a guidance document to explain the disqualification process.  No timeframe was given for completion. 

By Kurt R. Karst –      

The Medicines Company is reportedly continuing its multi-year and multi-million dollar lobbying effort to obtain a Patent Term Extension (“PTE”) for U.S. Patent No. 5,196,404 (“the ‘404 patent”) covering ANGIOMAX (bivalirudin), an anticoagulant drug product FDA first approved on December 15, 2000 for use in conjunction with aspirin in patients with unstable angina undergoing percutaneous transluminal coronary angioplasty.  The ‘404 patent expires on March 23, 2010, but is subject to a 6-month period of pediatric exclusivity that FDA granted in June 2009 after the Medicines Company conducted pediatric studies identified by FDA in a Written Request.  We understand that thus far The Medicines Company has been unsuccessful in its search for a legislative vehicle for its legislative fix, which has been dubbed the “Dog Ate My Homework Act.”

The Medicines Company submitted a PTE application to the PTO 62 days after FDA approved the company’s ANGIOMAX New Drug Application (“NDA”).  The patent term extension law at 35 U.S.C. § 156(d)(1) requires the submission of a PTE application “within the sixty-day period beginning on the date the product received permission under the provision of law under which the applicable regulatory review period occurred for commercial marketing or use” (i.e., within 60-days of the date of NDA approval).  In April 2007, the U.S. Patent and Trademark Office (“PTO”) denied the PTE request.  Among other things, the PTO cited Unimed, Inc. v. Quigg, 888 F2d 826; 12 USPQ2d 1644 (Fed. Cir. 1989), in which the Federal Circuit addressed the timeliness of a PTE application submission and observed that “section 156(d)(1) admits of no other meaning than that the sixty-day period begins on the FDA approval date.” 

As we previously reported (here and here), legislation has been introduced and debated over the past several years that would amend 35 U.S.C. § 156 to permit the PTO to accept the late filing of a PTE application, and in particular, The Medicines Company’s PTE application for the ‘404 patent.  In June 2008, Representative William Delahunt (D-MA) introduced, and the U.S. House of Representatives quickly passed by voice vote, H.R. 6344, which included a provision to amend 35 U.S.C. § 156 to add new subsection stating that the PTO Director “may accept an application under this section that is filed not later than three business days after the expiration of the 60-day period provided in subsection (d)(1) if the applicant files a petition, not later than five business days after the expiration of that 60-day period, showing, to the satisfaction of the Director, that the delay in filing the application was unintentional.”  (The 5-day petition period for a PTE application pending before the PTO would begin on the date of enactment of the law.)  However, there is a cost for unintentional delay.  The bill states that “[i]n order to effect a [PTE] under section 156(i) of title 35, United States Code, the patent holder shall pay a fee to the United States Treasury . . . .”  The fee for The Medicines Company is $65 million.  For other patent owners, the fee is determined based on a complex calculation.  Specifically, with respect to ANGIOMAX, H.R. 6344 states that a patent holder shall pay a fee equal to “(i) $65,000,000 with respect to any original application for a [PTE], filed with the [PTO] before the date of the enactment of this Act, for a drug intended for use in humans that is in the anticoagulant class of drugs.”  (H.R. 6344 failed to obtain Senate passage and died in the 110th Congress.)

The latest version of the “Dog Ate My Homework Act” reportedly being floated on Capitol Hill and obtained by FDA Law Blog, is substantially similar to the language in H.R. 6344.  It maintains the $65 million fee targeted to a PTE for a patent covering ANGIOMAX.  To build support for the legislative fix, The Medicines Company enlisted the help of PricewaterhouseCoopers (“PwC”) and is reportedly circulating with the proposed legislative language an 11-page PwC report titled “Impact of a Proposed Patent Restoration Under Hatch-Waxman on Federal Budget and Hospital Costs.”  According to the report:

[PwC], based on assumptions incorporated by CBO in its estimate of the patent restoration legislation, estimates that hospitals would have net savings of roughly $1 billion over the next 20 years if the patent for Angiomax was restored.  PwC further estimates, based on more recent data, that hospitals would have savings of $700 million in the first 10 years and $7.0 billion over the 20-year period FY2009-FY2028 if the Angiomax patent is restored.

The impact of patent restoration would be neutral to the federal budget during in the FY2009-FY2018 period, under the CBO assumptions, given the $65 million fee.  Net savings in hospital costs accruing in the FY2019-FY2028 period would result in net federal budget savings over the 20-year period, FY2009-FY2028, even under the CBO assumptions.  Further, using the assumptions about savings from the 2009 Premier data, patent restoration would result in $83 million in net savings to the federal government in the first 10 years as well.

The Medicines Company reportedly has not yet secured a legislative vehicle for its proposed legislation.  We understand that the company’s attempts to get the provision added to the Fiscal Year 2010 Departments of Commerce and Justice, and Science, and Related Agencies appropriations bill (H.R. 2847) have not yet panned out. 

Earlier this year, the PTO issued two new patents that The Medicines Company promptly asked FDA to list in the Orange Book as covering ANGIOMAX – U.S. Patent Nos. 7,582,727 and 7,598,343.  Several companies with pending Abbreviated NDAs (“ANDAs”) amended their applications to include a Paragraph IV Certification to the ‘727 patent (and presumably to the ‘343 patent as well), and the Medicines Company has initiated patent infringement litigation.  Because the ‘727 and ‘343 patents are later-listed patents, no 30-month stay of approval will apply to companies with pending ANDAs, as FDA has explained.

By Ricardo Carvajal –

The Smart Choices ProgramTM has announced “that it will voluntarily postpone active operations and not encourage wider use of the logo at this time by either new or currently enrolled companies.”  The announcement cites FDA’s recent letter to industry announcing the agency’s intent to define nutritional criteria for front-of-package and shelf labeling claims (see our prior post here) and notes the Program's desire to support FDA's initiative

By Larry K. Houck –

In an effort to combat a new aspect of the methamphetamine epidemic, Congress has introduced yet amendment to the Controlled Substances Act (“CSA”).  Representative John Boozman (R-AR) has introduced legislation in the House that would enhance criminal penalties for methamphetamine traffickers who target minors.  H.R. 3702, known as the “Stop Marketing Illegal Drugs to Minors Act,” was introduced on October 1, 2009.  Congress Boozman issued a news release stating that the bill “specifically targets flavored methamphetamine, a version of the drug specially colored, and specifically made to have a candy-like taste” noting that the Drug Enforcement Administration (“DEA”) has stated that traffickers are luring children with strawberry, chocolate and cola-flavored methamphetamine.

The bill would enhance criminal penalties for anyone who manufactures, creates, distributes, or possesses with intent to distribute, a flavored, colored, packaged or altered controlled substance to make it more appealing to minors.  Penalties would also apply to those who attempt or conspire to engage in these activities.        
  
The bill would subject first time offenders in cases involving 50 grams or more of methamphetamine or 500 grams of methamphetamine mixture with fines up to $8,000,000 for individuals and up to $20,000,000 for non-individuals and imprisonment of at least 20 years or life.  For first time offenders in cases involving between 5 and 50 grams of methamphetamine or up to 50 grams of methamphetamine mixture, the bill would impose fines up to $4,000,000 on individuals, up to $10,000,000 on non-individuals and imprisonment of between 10 and 80 years.  Penalties double for second offenses; fines quadruple for third or subsequent offenses and imprisonment increases to life.         

H.R. 3702 has been referred to the Committee on the Judiciary and the Committee on Energy and Commerce.