Friday, March 10, 2017
Donald Trump's FDA plans makes sense
When getting a new drug past the regulators can cost up to a billion dollars, it's no wonder that drug costs are so high. The manufascturers have got a huge investment to recoup. The probable Trump solution could cut costs drastically: Have the FDA rule on safety only, with efficacy left up to doctors to decide on, based in part on their own experience. Manufacturers will alway show what efficacy proof they have and manufacturers of rival drugs will always be quick to point to failures in efficacy trials of rival products.
The galoots below are so entrenched in their negativity that they say the new move will unleash dangerous drugs on to the market. How so? Nobody is proposing to lower the standards of safety testing. That should continue as before
Professor Rasko, with two international colleagues from Japan and Canada, has penned a comment article in the journal Nature published on Thursday calling for the US Food and Drug Administration to continue regulation of pharmaceuticals for both efficacy and safety.
In January, Mr Trump told pharmaceutical industry executives: "We're going to be cutting regulations at a level that nobody's seen before."
Professor Rasko, who is head of cell and molecular therapies at Royal Prince Alfred Hospital and affiliated with the University of Sydney, said: "The most extreme proponents of deregulation say the market should be the sole arbiter of utility: if a medicine sells well, then it must be safe and effective."
He told Fairfax Media: "If these sorts of changes go through, I can see a world in 10 years where the snake-oil salesman is back. It will all come down to marketing."
Mr Trump is vetting candidates for FDA commissioner. According to The New York Times, one candidate is Jim O'Neill, a former official at the US Health and Human Services Department.
At a conference on ageing in 2014, Mr O'Neill spoke in favour of "progressive approval" for drugs, which would see pharmaceuticals proved safe for use, but not shown to be effective for treatment.
Mr O'Neill said: "We should reform FDA so it is approving drugs after their sponsors have demonstrated safety. Then let people start using them at their own risk."
Professor Rasko has responded to what he regards as a global health threat. The authors say relaxing the FDA's regulatory system will subject patients to drugs that might be toxic.
Professor Terry Campbell, who is is head of the department of medicine at St Vincent's Hospital, said he was "inclined to agree with" the authors of the Nature article but noted "there is still a strong public health lobby in the US".
"Trials will still happen. Big cancer drugs won't be bought if they aren't proven effective."
Professor Campbell, who sat on the PBAC for 16 years to February this year, also said that even if the FDA changed its regulatory stance, "I can see no way that the Europeans would allow marketing without proving efficacy".
Professor Rasko in Nature argued that "unregulated markets are hopeless at sifting out futile drugs". "Witness the multibillion-dollar industries in homeopathy and other pseudo-medicines," the authors say.
Professor Rasko said: "Rigorous clinical studies are still the best way to learn whether a drug works and regulation is essential to ensure that these studies are conducted."
Senate Rescinds Obama’s Blacklist Rule
WH has indicated Trump will sign bill overturning rule that gave unions 'unprecedented new leverage'
The Senate voted to roll back an Obama executive order that would have shut out businesses undergoing labor disputes from obtaining federal contracts.
The Senate passed a resolution Monday evening to reverse the "blacklisting" rule, which would force companies to disclose any allegations of unfair labor practices when bidding for federal contracts. Previously, contractors were only forced to disclose actual violations that had been determined following agency investigations.
The Senate vote came weeks after the House approved a resolution overturning the rule. House Majority Leader Kevin McCarthy (R., Calif.) had made overturning the executive order a priority, pointing to a study that estimated compliance "will cost companies $454.6 million in the first year alone." Sen. Lamar Alexander (R., Tenn.), chairman of the Senate Committee on Health, Education, Labor, & Pensions, said that the executive order was overly burdensome because it would punish companies before investigations into the allegations could be completed.
“The harmful Obama administration ‘blacklisting’ regulation … could have prevented our nation’s federal contractors from receiving a federal contract for an alleged labor violation before any wrongdoing has been proven," Alexander said in a release.
President Obama issued the blacklisting executive order in 2014 saying that it would produce "economy and efficiency in procurement by contracting with responsible sources who comply with labor laws." The Department of Labor released its finalized rules in August 2016 after receiving tens of thousands of comments from businesses, organized labor, and other interest groups.
Labor law experts on both sides of the union divide recognized that the executive order would benefit unions. Veteran union attorney Robert Schwartz wrote in a blog post that it provided "unions unprecedented new leverage against companies" because they could potentially derail contract opportunities with an allegation no matter how specious. Trey Kovacs, a labor law expert at the pro-free market Competitive Enterprise Institute, agreed with Schwartz's analysis.
"The rule may provide incentive to labor unions, attempting to organize a workplace, to file frivolous labor-related charges against companies that bid on federal contractors in order to extract favorable union election conditions," he said in a post.
The National Labor Relations Board is the nation's top federal labor arbiter and handles unfair labor practice complaints. After an investigation the agency can file official complaints against the organization, encourage settlement between the two parties, or dismiss the charges. Workers and unions filed more charges in 2016 than in 2015, but the number of settlements and official charges fell. Workers filed 21,326 complaints to the NLRB in 2016, a five percent increase from 2015. The NLRB issued complaints in 1,272 of those cases—equal to the number in 2015 —and settlements were reached in 6,010 cases, a seven percent decline.
Business groups had turned to the courts to block the rule. Federal Judge Marcia A. Crone issued a temporary injunction against the rule in October because it potentially violated the due process rights of businesses. Associated Builders & Contractors, which filed the suit, praised the Senate for exercising its Congressional Review Act powers to reverse the rule.
"Congress has taken an important step in removing burdensome and duplicative reporting requirements and eliminating a costly barrier to entry that would have discouraged many small contractors from bidding on government contracts,” ABC spokesman Ben Brubeck said in a release.
The Senate resolution will now head to President Donald Trump's desk. The White House included the blacklisting rule in its list of Obama-era regulations that Trump wanted to overturn, saying that it "would bog down Federal procurement with unnecessary and burdensome processes that would result in delays, and decreased competition for Federal government contracts."
"Rolling back this rule will also help to reduce costs in federal procurement," the White House said. "The administration is committed to reducing onerous regulatory burdens on America's businesses and using existing authorities to continue enforcing the nation's workplace laws."
Trump has already taken action on some of the items on the list. He signed a bill in February reversing the Environmental Protection Agency's stream rules that had hindered coal mining for the past eight years.
The Trump Effect on your pocket
Here are two scenarios. One: you are a retiree who in recent years has been concerned about the value of your stock portfolio. Suddenly, the value of your stocks and stock-based mutual funds surges, the Dow rising 1,000 points to record highs within weeks.
You examine the monthly report your broker sends and you are pleasantly surprised at how much your investments have earned since Donald Trump took office.
Scenario two: You are reading and watching the news and all you see are stories about meetings between Trump campaign officials and the Russians, who have been accused of tampering with the election, though, according to The New York Times, law enforcement officials have said that none of the investigations “so far have found any conclusive or direct link between Mr. Trump and the Russian government.”
The media are obsessed with the Trump campaign’s alleged Russian connections, because, as their “reporting” and punditry has shown, they are no fans of President Trump.
If you are a retiree, or approaching retirement, which scenario most affects you? Do you care more about the Russians, or your increasing net worth? I thought so.
While some polls can be manipulated to produce outcomes based on the bias of the polltakers, this one by CNBC seems to reflect what the stock market is telling us. According to the financial network’s All-America Economic Survey for the fourth quarter, “the percentage of Americans who believe the economy will get better in the next year jumped an unprecedented 17 points to 42 percent, compared with before the election.”
Even more remarkable, the poll notes, “The surge was powered by Republicans and independents reversing their outlooks. Republicans swung from deeply pessimistic, with just 15 percent saying the economy would improve in the next year, to strongly optimistic, with 74 percent believing in an economic upswing.”
Of greatest interest for Republicans is the poll’s finding that optimism among independents doubled, though Democrat optimism declined by more than half. Maybe that has more to do with their failure to elect Hillary Clinton than the realities of the stock market, because one can presume their portfolios are doing well, too.
A Rasmussen Daily Tracking Poll found that as of last Friday “52 percent of likely U.S. voters approve of President Trump’s job performance. 48 percent disapprove.” Those numbers are likely to improve if the economy continues its upward swing and some of Trump’s promises are fulfilled, producing advertised results. Success is not only the best revenge; it is the best policy.
A recent Gallup poll put Trump’s approval rating at 43 percent with 50 percent disapproving of his job performance. In light of the incessantly negative media onslaught against Trump it is amazing he is doing as well as he is with the public.
Outside the beltway and inside the few remaining Democratic strongholds I suspect there is less concern about Russia and meetings between then-Sen. Jeff Sessions before he became attorney general and the Russian ambassador than how people think they are doing. “It’s the economy stupid,” reminded James Carville, campaign strategist for Bill Clinton. Remember?
The focus on Russia and “scandal” is the kind of petty politics that soured enough people in traditionally Democratic states to vote for Trump. They are tired of the games politicians play and want their government to work for them, not for the politicians and insiders.
If the Trump administration finishes its first year in office with demonstrable results, including a continually improving economy, the Left will have nothing remaining in its bag of tricks and that will make Democrats look even weaker and ineffective heading into the 2018 elections.
For more blog postings from me, see TONGUE-TIED, EDUCATION WATCH INTERNATIONAL, GREENIE WATCH, POLITICAL CORRECTNESS WATCH, AUSTRALIAN POLITICS, and Paralipomena (Occasionally updated), a Coral reef compendium and an IQ compendium. (Both updated as news items come in). GUN WATCH is now mainly put together by Dean Weingarten. I also put up occasional updates on my Personal blog and each day I gather together my most substantial current writings on THE PSYCHOLOGIST.
Email me here (Hotmail address). My Home Pages are here (Academic) or here (Pictorial) or here (Personal)
Posted by JR at 1:27 AM