Secured Additional Data Exclusivity for a Major Pharmaceutical Company
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Legislation was introduced that provided five years of additional exclusivity for new antibiotics intended to treat serious or life-threatening infections. The client, a leader in the field of antifungals, sought to amend the bill so that these products would likewise qualify for additional exclusivity.
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Executed a bipartisan lobbying effort focused on educating the bill’s sponsors and other lawmakers on the House Energy & Commerce and Senate Health, Education, Labor & Pensions (HELP) Committees on the need to include other antimicrobials, such as antifungals. The campaign focused on both the increased costs to society and the healthcare system posed by the paucity of effective antifungals, as well as the critical importance of data exclusivity in encouraging investment and continued innovation in this largely overlooked segment of the market.
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Lawmakers expanded the definition of a “qualified infectious disease product” to include antifungals and the measure was signed into law.
Ensured a Level Playing Field for a Leading Manufacturer of Branded Biopharmaceuticals
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When one of the world’s largest biopharmaceutical companies was faced with an extension of a transitional pass-through payment program under Medicare that would have given biosimilar competitors an unfair advantage, they enlisted the help of Roberti Global.
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Engaged and educated lawmakers in House and Senate leadership, as well as those serving on relevant committees of jurisdiction, on the history of the pass-through program (e.g., its limited application to innovator products) and the perverse incentives created by its application to biosimilars (e.g., encouraging hospitals to use biosimilars even in cases where the branded biologic is the better and lower cost option). Result: Roberti Global successfully limited the scope of the extension such that the pass-through payments inured to the benefit of only a handful of products – none of which were competing biosimilars.
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Roberti Global successfully limited the scope of the extension such that the pass-through payments inured to the benefit of only a handful of products – none of which were competing biosimilars.
Helped two of the largest telecom companies navigate a $69 billion merger with the FCC
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Worked with two of the largest telecommunications companies in the United States, wanted to merge in order to become a more effective and efficient provider in the wireless, broadband, video, voice and data markets. The decision to allow the merger was stalled at the FCC with no final decision in sight. Our client enlisted our help in building support on the Hill to prompt the FCC to take action.
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Highlighting the benefits in service and savings to American consumers, we were able to cast the merger in a favorable light and build support for it among Members of Congress. Further, using our ability to navigate through both the FCC and Congress, we were able to bridge the differences between the two bodies and craft a solution agreeable to all parties involved.
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We were able to get the FCC to approve the historic merger in a timely manner on terms favorable to the client.
Secured U.S. Senate support for one of the world’s largest software companies
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European regulators objected to the proposed $7.4 billion purchase, one of the world’s largest software companies. The move would transform our client into a major manufacturer of hardware as well as software products.
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Devised a bipartisan Hill outreach strategy to educate U.S. Senators about the potential loss of American jobs caused by the merger’s delay, and to have them pressure European regulators to complete their investigation and justify any further opposition.
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Succeeded in having 59 Democrat and Republican Senators send a formal letter to the European Commission urging them to hasten their deliberations. European regulators unconditionally approved the merger.
Protected the telecommunications industry from billions of dollars in potential liability
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Telecommunications companies that had cooperated with federal government surveillance efforts faced the specter of multi-billion lawsuits for alleged violations of the Foreign Intelligence Surveillance Act of 1978 (FISA).
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Implemented a strategy that focused on enlisting the support of congressional leaders, as well as key members on the House Homeland Security Committee, House Intelligence Committee, Senate Select Committee on Intelligence, and Senate Homeland Security and Government Affairs. Engaged in a comprehensive campaign to educate lawmakers on the impact of these lawsuits and the need to protect telecommunications companies from unfair penalties in order to encourage their compliance in the future.
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Congress passed the FISA Amendments Act of 2008, which provided blanket retroactive immunity to telecommunications companies.
Providing relief to a global banking and financial services company from excessive regulation
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The Dodd-Frank financial regulation bill included an onerous provision that required banks to hold certain securities in special subsidiaries that did not benefit from government banking in the form of FDIC insurance and access to the Federal Reserve’s lending windows. With their ability to limit risk on certain loans severely curtailed, the company turned to Roberti Global.
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Developed and executed a message strategy that communicated the importance of using these instruments in limiting risk and convinced key lawmakers that the restriction was not only excessive, but harmful to consumers.
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Working together as part of an all-hands-on-deck approach, Roberti Global was successful in repealing the offending provision.
Averting a crisis for the airline industry and ensuring the continued safety of passengers.
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As a result of the across-the-board funding reductions in federal programs through the budget sequestration process, the Federal Aviation Administration (FAA) began to furlough personnel, including 15,000 air traffic controllers, and moved to shut down 149 of 516 air traffic control towers in the U.S. The cuts put airline passengers at greater risk, resulted in thousands of flight delays, and had an adverse impact on the communities served by these airports.
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Devised a bipartisan, bicameral strategy to build support for legislation aimed at giving the FAA greater flexibility to prevent reduced operations and staffing. This included a tailored education campaign for a core group of lawmakers that explained the harmful effects of sequestration on the FAA, with an emphasis on safety, jobs, and the economy. Offered a reasonable solution that did not require Congress to either authorize or appropriate any additional funding.
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Legislation was passed that allowed the FAA to waive the sequestration rules and divert $253 million from an existing grant program to pay for personnel costs, averting what could have been a crisis for the airline industry, passengers, and the countless businesses that serve them.
Helping a major automobile manufacturer secure a vital tax benefit for domestic capital investment
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When an automaker sought a change in the tax code to strengthen and expand their American operations, they enlisted the help of Roberti Global.
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Developed an aggressive education campaign for a core group of bipartisan lawmakers that explained the benefits of allowing businesses to collect alternative minimum tax (AMT) credits that they would not otherwise receive because they did not pay enough taxes in recent years to claim a rebate. This included a message strategy focused on how the change would incentivize domestic capital investment in plants and equipment, and preserve and stimulate the creation of additional American jobs.
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Secured a change in the tax code that allowed automakers to collect AMT credits of up to $40 million a year, regardless of their tax obligation.
Safeguarded a Multibillion European Energy Project from U.S. Sanctions.
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When a multibillion-dollar natural gas pipeline consortium in Central Europe found itself caught up in the politics of Russian sanctions legislation, they enlisted the help of Roberti Global.
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Engaged lawmakers serving on key House and Senate committees by explaining how the project had no affiliation with the offending parties and how any proposed sanctions should be done in coordination with our European allies. Additionally, working with the Executive Office of the President (EOP) and the federal agencies, Roberti Global was able to convey the importance of the project to our nation’s allies, as well as its distinction from targeted sanctioned entities.
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Roberti Global was able to secure changes to the legislation – along with an explicit signing statement from the White House – clarifying that the President would coordinate with our European allies before imposing any such sanctions.
Mitigated a Safety Recall Crisis for a Leading U.S. Automaker
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When a domestic automaker discovered that a potentially life-threatening safety defect had not been properly reported by the company’s previous leadership, Roberti Global was called upon to help manage the company’s response and mitigate the fallout.
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As part of an all-hands-on-deck approach, Roberti Global took a lead role in helping prepare the CEO and other top executives to testify before a congressional oversight and investigation hearing, as well as shaping and conveying to both federal lawmakers and agencies the quick and decisive action that was taken to correct the specific safety issue and the underlying reporting failures that created the situation in the first instance.
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Roberti Global was successful in mitigating the reputational and political fallout, preparing the client to testify in an open public hearing, and implementing a solution to protect consumers moving forward. The Company’s testimony and overall response was roundly praised by lawmakers and consumers for their candor, proactive measures, and effectiveness.
Helping one of the Largest Consumer Electronics Brands Navigate a Safety Recall and FAA Ban
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When the marquee product for one the world’s largest consumer electronics companies was faced with a safety recall and having the Federal Aviation Administration (FAA) ban their products from all U.S. flights, they turned to Roberti Global.
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Devised and implemented a comprehensive strategy to communicate to both lawmakers and the FAA all of the steps being taken by the company to remove the affected devices from circulation and, more significantly, how the defect in question had been identified and resolved.
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Roberti Global succeeded in having the FAA lift its ban on the company’s other products.
Mitigated a Crisis for the Compounding Pharmacy Industry
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The nation’s premier advocacy group for compounding pharmacists approached Roberti Global for assistance after several hundred patients were infected, some fatally, with meningitis from contaminated products sold by a non-member pharmacy.
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Engaged lawmakers serving on key House and Senate committees by explaining how the organization had no affiliation with the offending pharmacy and, more importantly, how the actions of that pharmacy were in complete contravention of the standards and practices of both the organization and industry. As the committees worked on crafting legislation, we educated them on compounding pharmacy practices and ensured that the organization not only had a seat at the table, but that its views and concerns were both effectively conveyed and incorporated throughout the entire process.
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Through Roberti Global’s efforts, a legislative proposal that would have imposed several onerous mandatory legal and regulatory requirements on the industry was averted. Instead, the legislation passed by Congress emphasized the enforcement of existing laws, provided a “safe harbor” for traditional pharmacy compounding, and created a new, voluntary program for large scale compounders that required adherence to cGMPs – but exempted products from FDA approval and labeling requirements.