Opinion: WILL THE FDA AND PHARMACEUTICAL INDUSTRY CRONYISM PERSIST UNDER TRUMP?

By Michael McGrady

The short answer is: “yes, but with some challenges and it won’t be as strong.”

But, please, allow me to go into context. The U.S. Food and Drug Administration, like several federal regulatory bodies, has experienced near immunity and lack of accountability in its dictation over the compliance landscape for many consumer products.

The FDA exemplifies self-empowered influence, continually regulating the pharmaceutical industry so tightly that it has killed new or biosimilar medications before they reach the marketplace, solidifying monopolies on medications. This crony capitalistic practice secures more market share and influence for major industry players, preventing healthy competition in a free market.

Now, with the Trump Administration already making or preparing to make sweeping changes throughout all areas in the executive branch, the FDA may face a major change, as well.

To his credit, President Trump has vowed to slash regulations with his “1 in, 2 out” mandate for all new regulatory guidance created by federal agencies.

In effect, for every one rule created, two old rules must be eliminated. This could lead to a major reduction in the regulatory regime that has engulfed several sectors of the American economy, including the pharmaceutical industry.

Certain rules passed in the lame-duck session to cap off Obama’s sundering FDA. The agency passed 20 rules and guidance regulations to furnish the legacy of the former president.

Several rules like those pertaining to stricter manufacturing practices and updating drug approval applications were directly challenged by the rule. Other rules pertained to the promotion of biosimilar and prescription medications. Many of the final rules were at major risk of getting shelved if not published by Obama’s FDA before the transition of power was complete in late January.

According to Real Clear Politics, the new president met with pharma executives to come up with an effort that can, effectively, get down prices for drugs.

“President Trump called for drug companies to get prices down, accelerating the FDA approval process, getting drugs to terminal patients, reducing the price of research and development, getting rid of some regulations,” according to the coverage via the report.

Nevertheless, even the slightest reduction in regulations is a win-win scenario. One major area of concern for many yielded to how the Trump FDA will deal with scandals like the Mylan incident where EpiPen prices rose astronomically.

One possible solution that the administration could employ, especially in an effort to control drug prices and rein in health expenditures for consumers, would be to compel the FDA to focus more on approving biosimilar drugs to compete with original products.

An example of this, as I reported for The Heartland Institute, was when the agency approved a biosimilar for Humira, the world’s bestselling drug.

Dr. Richard Dolinar, a practicing endocrinologist and pharmaceutical industry consultant, said in my report that “[Biosimilars] will bring competing drugs to the market at a lower price than the innovator company is currently charging, and by doing so, more patients will have access to these very expensive lifesaving and life-altering drugs. . . . Competition does not destroy free markets. Only government can destroy free markets.”

Biosimilar drugs are often proven to be effective, according to the National Institutes for Health. In addition, since the biosimilarities of these drugs are closely related to other key drugs that monopolize the specific segment of the market, the drugs are presented with more competition.

With more competition, the larger companies are forced to drop prices and, as we learned in Economics 101 class, let the best product win.

Biosimilar medication approvals, though, are only a handful of options that can promote free markets and a pro-business, market-friendly governmental presence in the industry.

Regardless, one thing that is for certain is that since the election of Donald Trump, publicly traded pharmaceutical and biotech companies have been performing exceptionally well.

This performance is mostly due in part to Trump’s then-little words on pharmaceuticals and making drugs more affordable.

Despite what it is, though, the FDA is ripe for widespread changes. We can see the beginnings of a breakup of the revolving door of the agency and pharmaceutical establishment.

Originally published by Capitalism.com.

Opinion: “Fake News” Is Still Subject To Freedom Of Speech And Press

By Michael McGrady

Let me be very clear…

I don’t care if our president liberal or conservative, democratic or republican, the freedom of speech and press are two constitutional mandates we have built our country on.

If you haven’t heard, the Trump Administration hand-picked media outlets to join Press Secretary Sean Spicer for a gaggle in his office. Simply put, the intention of the “hand selection” of who can and cannot join a White House press briefing, especially in the instant, shows some blatant disregard for differing editorial slants, in part by the administration.

Trust me, I am no fan of CNN, the New York Daily News, and Buzzfeed (a few of the outlets blocked for an off-camera press gaggle). Several of those publications drop to new lows in reporting; yet, even in the ignorant distribution of misinformation (all media included, even myself), constitutional rights supersede a childish dislike of the media.

The events of today present a scenario that many didn’t expect. Being one of the many to vote for Donald Trump and rest all of our future interests on his presidency, I can maybe speak on the behalf of many conservatives and libertarian types that view this as a smack in the face to document and virtues he swore to protect.

Though I will face ridicule from many members of the nationalist flights of the Republican Party, freedom of speech and press resides as one of the most important freedoms to people. Even members of the “fake” news media are entitled to such protections, even if they feed the masses lies.

In the First Continental Congress, in the Appeal to the Inhabitants of Quebec, many of our founders broadly characterized the freedom of the press as a very sacred right.

“The last right we shall mention regards the freedom of the press. The importance of this consists, besides the advancement of truth, science, morality, and arts in general, in its diffusion of liberal sentiments on the administration of Government, its ready communication of thoughts between subjects, and its consequential promotion of union among them, whereby oppressive officers are shamed or intimidated into more honorable and just modes of conducting affairs,” the Appeal proclaimed.

As I mentioned above, this definition of a free press is monumentally broad. Though it mentions the “advancement of truth,” I personally define this component to be truth to the perspective of the publisher of the alleged remark that embodies some truth.

This very occurrence should remind us that the United States was, and still is, a marketplace of ideas, cultures, and people.

Originally published by The Daily Caller.

Opinion: Yep, Let’s Talk About North Korea Again

By Michael McGrady

A week cannot go by without the news media covering the “Hermit Kingdom” of North Korea. Even way before the recent ballistic missile tests and Kim Jong Un allegedly killing his own brother via female assassins, dealing with the North has been tricky and life-threatening. If you’re a history buff, as I am, you will know that the Korean War was one of the most costly conflicts of the Cold War era. Hundreds of thousands died on all sides, as the war was one of the most ambitious gambles of Maoist China and the Soviet Union.

Regardless of the backdrop and the gruesome loss, one of the biggest things that can be often overlooked by the casual onlooker is that the Korean War never really ended, ergo only an armistice, not an official peace treaty, was ratified. So, technically, the conflict never ended.

These remarks lead me into the key takeaway that I wish to leave you at the completion of reading this op-ed… There are billions of innocent people between places like Pyongyang, Beijing and, of course, Washington D.C., literally. Billions depending on the select few to guide them as their leaders, despotic or not.

I say this because one of the most important things to realize in our current state of affairs is that we are in the midst of a nuclear North Korea. President Donald Trump has said, at least on the public surface, that the current regime of Kim Jong Un is a viable threat to American national security and the very delicate international stability the world Is currently in (besides the Central Asia crises).

With recent diplomatic developments, especially in part to China’s surprising leadership in barring North Korean coal imports to enforce United Nations sanctions, the times have never been tenser when negotiating or attempting to bring stakeholders to the negotiating table.

As I pointed out in an op-ed from last week on the North Korea problem, the relationship between the Chinese and the North Koreans is unique and merits further analysis. Simply put, China does have a deep fear of a nuclear North Korea due to the inevitable threats of Western intervention. Due to this, a deeper fear in the Chinese government attributes to the country’s need for a “buffer state” between the U.N./U.S. backed South Korea and 30,000 American serviceman ready to kick some butt. Nevertheless, though, the Chinese government, the only real ally with the North Korean government, has no interest in armed conflict with the west. Merely, the frustrations are channeled into a never ending series of trade disputes that are commonly left alone, resolved through diplomatic channels, or that just simply vanish.

Aside from all the internal politics of the American-Chinese relationship, Jinping’s China does serve as the only possible way to diplomatically communicate with a country that is, nearly, 100% cut off from the entire world. The United States doesn’t even maintain and official diplomatic mission to the North.

With a presidential administration that is more conservative than its predecessor, a Trump foreign policy will derive from his “America First” doctrine. In this case, though, the administration needs to put national security first. By no means do I advocate the “nuke ’em all option,” however, the latter argument is that the typically eased show of force is effective.

Firstly, one key approach that can be taken to open up the dialogue is to, as aforementioned, get Beijing to grow a pair and face the realities of a nuclear North Korea.

Secondly, the United States, its partners, and the United Nations need to effectively freeze and seize foreign assets held by North Korean financial institutions, leaders, companies, or agencies. The sanctions should also be focused on all efforts and entities that help promote pro-North nuclear proliferation. Military intervention isn’t off the table in this scenario, either.

But, in the end, though, one of the main approaches should be to renew the defense commitment to free-Asia the United States military already maintains while working to allow regional powers to take the lead and address the problem. Cooperation is only the best possible way to approach any solutions in this precarious case. Unilateral actions against North Korea are near-suicidal at this point, to say the least.

Originally published by The Daily Caller

Opinion: Flynn Removed Himself So He Could Own Up To His Mistakes

By Michael McGrady

Author’s note: The below version of this op-ed was published prior to the realization that General Flynn was told to hand in his resignation to the President. 

Normally, it is not characteristic of me to speak foul of people charged with supporting the mission of our country’s national security; however, today is a special occasion, I must sadly report.

Michael Flynn served his country admirably as one of the many well-respected leaders of the Defense Department. In fact, he was viewed with high regarded by superiors and subordinates when he led entities like the Defense Intelligence Agency. We all owe him a lot for serving our country in these many capacities, during his noteworthy career in public and military service.

Nevertheless, even roses have thorns – and can draw blood.

Lieutenant General Flynn is a victim of not only circumstance but of his own design. To begin, intentional or not, in his short role as the Trump Administration’s senior national security advisor, he communicated misinformation to Vice President Michael Pence. Such an act cannot go unpunished.

For the longest time, cases such as this (military greats falling from grace for acts of pure stupidity) should provide the American people the 30,000-foot view that all people in government need to be held accountable.

In the initial stages of the Administration’s transition of power, President Trump tried to make a “dream-team” of national security experts that understood how the field works. Flynn was the guy and we cannot deny this. In the end, as we have seen, even the cream of the crop gets complacent to their roles in the food chain of American government.

Flynn, in his resignation, indicated, that, “Throughout my over thirty-three years of honorable military service, and my tenure as the National Security Advisor, I have always performed my duties with the utmost of integrity and honesty to those I have served, to include the President of the United States.” Honored he should be.

Despite all of this, though, Flynn’s resignation is indicative of the importance of maintaining the status quo of national security application. He acted in a capacity that is not acceptable, though very rare, is punishable by harsh reprimands. Knowingly speaking to foreign actors on matters of such levels like sanction removal can also spell delinquent state of affairs.

Foreign policy is not a game. Even to what seems to be littlest mistakes, like the actions of Flynn communicating with the Russian Ambassador in such a manner, can spell out disastrous ramifications for international relationships, U.S. Foreign Service personnel, and our armed forces.

“I am… extremely honored to have served President Trump, who in just three weeks, has reoriented American foreign policy in fundamental ways to restore America’s leadership position in the world,” Flynn further laid out in his resignation. Reality caught up to us, sadly.

Flynn was a good egg and he will be missed, I am sure. In the end, though, the Administration’s mission is to put “America First.” In an attempt to sound less crass about it, Flynn’s resignation is a step in the right direction to achieve such a goal.

God’s speed, General. I wish you the best of luck and thank you for your service to the American people.

Originally published in The Daily Caller.

Opinion: Things Aren’t Simple When It Comes To North Korea

By Michael McGrady

Continuously, the threats spewing from the Democratic People’s Republic of Korea (DPRK), or North Korea, have put the United States and its partners in a precarious position. This is especially the case with the new presidential administration and when relations between the DPRK and the West are so tense, you can cut through it with a knife.

To test the prowess of President Donald Trump, Kim Jong Un and his hard-lining advisers authorized a ballistic missile test on Sunday. Merely, this test launch is representative of two things. The first: the North Korean government is trying to be the bold power they yearn for. The second: to expose any weakness associated with the President’s approach to dealing with the totalitarian regime.

Regardless, though, all eyes are turned onto the Trump White House as the Administration is faced with the question of how they wish to respond without escalation.

In a statement on the launch from U.S. Strategic Command, one of nine unified combatant commands under the leadership of new Secretary of Defense Jim Mattis, the launch was no obvious threat to the United States or its allies, per the detection that the projectile crashed into the Sea of Japan as a part of the test. Nevermore, Strategic Command, including other cohorts of the federal government, have voiced the major concerns surrounding this launch as it contributes to the overarching concern of how North Korea is a legitimate national and international security threat.

Bloomberg, in an analysis on the events of late, quoted Richard Haass, president of the Council on Foreign Relations, in stating that the continued threats from the DPRK, though empty at the current moment, still present a troubling matter.

Haass, on CNN via the aforementioned report, pointed out that, “Trump is going to have to face a truly fateful decision about whether we’re prepared to live with that, a North Korea that has that [nuclear] capability against us, or we are going to use military force one way or another to destroy their nuclear missile capability.” Essentially, Haass is calling the probability of Trump having to make a landmark decision on America’s approach to the DPRK threat to be very high. From my own observations, such a realization is not as far-fetched and can have overwhelming ramifications for both countries, and the entire world.

President Trump, siding with many international leaders, have vowed to address the North Korean threat by several means. The most salient means for Trump is to contribute to the ignition of the next Cold War by following courses of action that illustrate the force of the United States military. Ergo, the development of THAAD countermeasures and continuing with the foreign policy approach that is pro-South Korea. But, the state of affairs we find ourselves in also indicates the need for dealing with North Korea bilaterally, rather than unilaterally.

With this sentiment, the United States, under Trump’s leadership, needs to consider the fact that dealing with states like North Korea requires us to side with diplomatic and geopolitical adversaries like China and Russia.

In the instance of the most recent launch, Russia joined with the United States, Japan, the NATO-block and several United Nations members in condemning the tests. China has remained, ultimately, silent, no surprise there.

In the case of utilizing Russia for proxy foreign affairs, the United States will find a challenge, to say the least. Besides getting past the issues both countries have, what appears to be the only chance Putin’s Kremlin will authorize joint efforts with the U.S. is determined on whether China will be involved or not. Thus, we find ourselves back to square one.

International leaders like Japanese Prime Minister Shinzo Abe has protested the DPRK nuclear test via contending to the graces of China. Chinese president Xi Jinping, however, must be lobbied aggressively to make any defamatory actions against Un and the DPRK’s sitting regime. Trump needs to institute a policy approach that brings the stakeholders to the table, including Jinping, Un, himself, and other salient actors like Abe and the next South Korean president (obviously after the country heals from the aftermath of the Park Geun-hye scandal and the current election).

Nevertheless, though, my ending argument, simply put, is that all international actors need to understand that the “same-old” foreign policy isn’t working. For Trump, he needs to utilize the expertise of Secretary Rex Tillerson, hold China accountable for reining in Pyongyang with cooperation and secondary sanctions and even bring in the insights of Congress via such channels like enforcing the North Korea Sanctions Enforcement Act of 2016.

For China, Jinping’s government needs to cooperate with the international community and not sit idly by as North Korea gains nuclear capabilities. As Bruce Klingner, a senior research fellow for Northeast Asia at The Heritage Foundation’s Asian Studies Center, spells out in a 2016 op-ed for The Daily Signal, “North Korea is willing to directly challenge China’s calls for peace, stability, and denuclearization by repeatedly upping the ante to achieve its objectives—including buying time to further augment its nuclear and missile capabilities.” Klingner’s observations cited the clearly apparent lackluster dedication China has when it faces North Korea. All of it is due in part to the country’s own fear.

In the end, though, time and responsive diplomacy can only dictate the outcomes. North Korea has placed the entire world on edge since the final days of Kim Jong Il and his son, Jong Un, rose to power. The solution isn’t as simple as nuking the unicorns, allegedly discovered by the DPRK, and the communist hardliners in the regime.

Originally published in The Daily Caller

Opinion: The Prodigal Interior Department

By Michael McGrady

U.S. Representative Ryan Zinke (R-MT), Trump’s pick to head the Interior Department, has a lot to do once he assumes his new position. For starters, let’s start with addressing the Interior Department’s massive corruption epidemic.

For far too long, Interior officials have been on record, abusing their power and status to advance personal agendas, make personal gains, and bullying innocent taxpayers into submission. And no, I am not just talking about the seizure and outright infringement of the private property rights of millions of Americans. I am referencing the aforementioned epidemic of corruption that has engulfed the agency since the beginning of the Obama Administration into the transition to the Trump Administration.

Usually, many of the cabinet-level agencies in the executive branch have independent auditors and watchdog organizations, known as an Inspector General, to focus on detecting fraud, waste, and abuse in the day to day operations of the agency. However, how can an agency rot with corruption trust an independent source if the entity is compromised itself? The simple answer is that it cannot fix corruption issues if corruption is at the top.

In the middle of last year, Republican Congressman Louie Gohmert inquired into the department asking the agency’s acting Inspector General, Deputy Inspector General Mary Kendall, to address cases of “exacerbating corruption.”

Gohmert’s letter, signed in his role as the chairman of the House Natural Resources Subcommittee on oversight and investigations, mentioned that citing a recent corruption report from the DOI OIG, “These are troubling findings, and serve as further evidence of exacerbating corruption within the Department of the Interior.” The OIG report cited covered the findings and course of actions surrounding the case of corruption advertently committed by former Bureau of Land Management (BLM) head Bob Abbey.

Other instances that illustrate the level of corruption in the DOI can also be seen with the troubling investigation of Deputy IG Kendall herself, in 2013. The Congressional inquiry stated that the OIG, under Kendall as acting head, was mismanaged. “These [accusations] include: not pursuing investigations involving political appointees or Administration priorities; informing senior Department officials of problems without conducting formal investigations and not issuing reports to Congress and the public; not adequately documenting the management of IG investigations and operations; serving in an appointed policy role in conflict with the IG’s investigative duties; preventing an investigator from seeking information from a White House official; and providing inaccurate and misleading information to Congress,” a public release on the report stated.

Though Kendall still remains in charge of the watchdog and, according to an external perspective, holding agency employees and leaders accountable has been lackluster, at best.

One of the most recent cases of this can be attributed to the BLM official utilizing his position, and the power that comes with it, to get preferential treatment, use agency law enforcement officials as personal escorts, and score tickets to the 2015 Burning Man festival.

Another, more recent case, pointed to the corrupt usage of a government charge card by employees of the U.S. Geological Survey. In the end, the case concluded that over $12,000 of credit, charged by USGS employees, was abused and wasted. Plus, to no major surprise, the list of abuses keeps going and going.

Nevertheless, here is the real paradigm we are faced with: Trump and Zinke rooting out corruption…

One of the major challenges, once Zinke is confirmed, needs to focus his efforts on cleaning house in his immediate staff, working with the agency directors and the OIG to reign in unchecked power and abuse by employees and leaders of the agency, and to reaffirm the agency’s role. Sadly, it is not as simple as de-funding the agency; but, more or less a recovery period to streamline and shrink DOI’s presence.

Originally published on RedState

Opinion: International Religious Liberty Is Vital, And Trump Needs To Advocate For It

By Michael McGrady

For the longest time, the world has watched in horror as thousands across the world have suffered at the hands of despotic governments due to oppressed peoples merely exercising their naturally endowed right to freedom of conscience.

We open our scene on the People’s Republic of China (PRC) where thousands of people from of all faiths are unjustly imprisoned for their beliefs and forcibly submitted to horrendous live organ harvesting and torture so that the Communist-controlled government can assert their dominance over thought and culture.

Last year, a colleague and I wrote, in a column for The Blaze, on the importance of ensuring international religious freedom utilizing the faith of Falun Gong and the pain this group continuously suffers as an example, to illustrate need for Americans (especially) to lead the fight in promoting an international environment where religious freedom can flourish absent of despotic intervention.

We indicated that “while many groups in China and around the world are attacked for holding “strange” beliefs, Falun Gong members have been claiming for more than a decade the persecution against them has taken an especially dark turn.” This dark turn, obviously, is the egregious acts of the sitting Chinese government to forcibly extract organs for donation purposes from living “prisoners of conscience” – which includes groups like Chinese Christians and the Uyghurs, of whom are a Muslim majority.

The United Nations has investigated this overt violation of life, liberty, and the pursuit of happiness for these prisoners of conscience; but the Chinese government continues to provide organ donation services at relatively low prices and retrieval times, ergo citing some crooked practices in part of the public health officials. Thus, this only lends credibility to the already confirmed fact that the Chinese government is killing its citizens of whom disagree with the majority ideology of Maoist Communism. Simply put, the Chinese government remains unchecked.

American President Donald J. Trump is now presented with a new paradigm in conducting foreign affairs on behalf of the free world. With this, the Trump Administration needs to recognize the importance of protecting religious liberty and freedom of conscience, not just domestically but, abroad. Nevermore, the question remains: “What is the proper way for Trump to help support and affirm international religious liberty?”

For starters, Trump needs to put despotic governments, like the PRC, on blast for oppressing freedom of conscience amongst its citizens. One way of doing this is for the newly confirmed United States Ambassador to the United Nations Nikki Haley to challenge the very representatives of communist and fascist dictatorships, like that of Xi Jinping’s PRC, on the matters of human rights. Trump via Haley needs to leverage the UN’s Universal Declaration of Human Rights (UDHR) in favor of victims of despotic regime rule.

Article 18 of the UDHR directly states that, “everyone has the right to freedom of thought, conscience, and religion; this right includes freedom to change his religion or belief, and freedom, either alone or in community with others and in public or private, to manifest his religion or belief in teaching, practice, worship and observance.”

With America’s influence over the UN, President Trump must use such influence to rout out the dissidence of oppressive governmental intervention, no matter the country, on a human’s promulgated right to think and believe freely.

Trump also has the intuitive insight of the United State Commission on International Religious Freedom (USCIRF), a federal commission committed to advocating for freedom of conscience and faith across the world, at his disposal. USCIRF and its commissioners provide a level of expertise from the private and the public sector on how foreign governments should recognize and protect religious freedom for their populace that is unmatched.

In the current case on religious liberty in China, USCIRF, in their 2016 annual report concluded that in this past year, “China’s severe religious freedom violations continued.” The report recounted for the Chinese government repressing on several precarious incidences including cases where Uyghur Muslims being prohibited from practicing Ramadan to Christians within the country facing regulations prohibiting sympathetic religious symbols in the public square. Moving away from the atrocities that people of all faiths face in countries like Communist-controlled China, USCIRF serves as the only credulous source on religious freedom across the world in place at the federal level.

Last year, though, the Republican-held House of Representatives even passed a resolution acknowledging the importance of addressing the forced organ harvesting horror for the Falun Gong and all faiths subject to such degradation.

The final argument, in the end, is simple: President Trump has the leverage and the tools to effect positive change for the international faith community. It should be in his Administration’s best interest to ensure that this happens. It is well overdue.

Originally published on The Daily Caller